年収1,400万円以上／医薬品の求人・転職情報| ハイクラス転職エージェント JAC Recruitment

Commercial FP&A Manager~Senior Manager

外資系ヘルスケア業界

課長以上
外資系企業

仕事内容

・コマーシャル部門のファイナンスパートナーとして、売上分析、経営層向けの提言、改善策の提案
・担当領域の売上予測および売上計画主導
・予算策定、ローリングフォーキャスト、中長期計画の策定
・定期的な売上実績レポートを作成・管理
・予算・予測差異分析

求める経験 / スキル

・7年以上のFP&A経験
・マネージャー：業界経験不問
・シニアマネージャー：ヘルスケア業界経験必須

勤務地

東京都

想定年収

1,600 万円 ~ 非公開

QA Senior Manager_ Biopharma

メルクバイオファーマ株式会社

課長以上
外資系企業

仕事内容

In this pivotal role, you will shape and oversee the local quality strategy for Japan, protecting patients and supporting reliable access to medicinal products. You will lead quality and compliance activities across good manufacturing practice, good distribution practice and good quality practice, translating global direction and the Pharmaceutical and Medical Device Act into practical standards and a robust quality management system. You will guide complex operational issues, including changes, deviations, complaints, recalls and corrective actions, while coordinating inspection readiness with manufacturing sites and health authorities. By advising local management, leading quality councils and management reviews, and connecting local, global and external stakeholders, you will strengthen performance, risk management and continuous improvement across the area.

求める経験 / スキル

・Degree or equivalent background in pharmacy, chemistry, life sciences, pharmacology, medicine or a related field.
・At least 3 years of experience in the pharmaceutical or related industry, with exposure to quality assurance, manufacturing, distribution, warehouse operations or related activities.
・Practical experience with good manufacturing practice, good distribution practice and good quality practice in Japan, together with experience in quality assurance systems.
・Working knowledge of Japan’s regulatory framework, including the Pharmaceutical and Medical Device Act, and experience supporting health authority inspections.
・Experience managing quality processes such as change controls, deviations, technical complaints, product recalls or withdrawals, quality risk management and corrective and preventive actions.
・Ability to analyze complex operational issues, prioritize work and make sound decisions with substantial professional responsibility.
・Strong collaboration, negotiation and influencing skills to work effectively with local, global and external stakeholders.
・Willingness to travel nationally and internationally; basic project management experience and familiarity with standard office applications are beneficial.

従業員数

273名（メルクバイオファーマ（単体）2026年3月時点）

勤務地

東京都

想定年収

1,148 万円 ~ 2,025 万円

従業員数

273名（メルクバイオファーマ（単体）2026年3月時点）

Corporate FP&A Manager - Senior Manager

外資系製薬メーカー

課長以上
外資系企業

仕事内容

・日本法人全体のP/L（損益計算書）の統合
・予算やフォーキャスト、中長期計画の策定・取りまとめ
・PL、OPEX、人件費分析
・コーポレート部門のファイナンスビジネスパートナーリング

求める経験 / スキル

・5年以上のFP&A経験

勤務地

東京都

想定年収

1,200 万円 ~ 1,600 万円

Ethics & Compliance

大手メーカー

外資系企業
部長以上

仕事内容

■E&C Program Management

•Assess compliance communications and training needs for the affiliate to effectively support ethics and compliance program needs and organizational change management goals and objectives.
•Conduct regular E&C risk assessment of affiliate practices and work with leaders to put in place appropriate responsive actions.
•Design and execute monitoring plans for the affiliate to address identified and prioritized risk areas.
•Consult on investigations with ethics and compliance implications and always collaborate with HR on speak up and investigations.
•Drive application of effective corrective and preventive action plans responsive to monitoring and investigation findings.
•Deliver meaningful insight to affiliate leadership derived from monitoring and other activities.
•Represent Japan externally with industry Ethics and Compliance peer groups, the industry association, and regulators, not only to understand the external environment but to influence and shape it, including by promoting high ethical standards across the pharmaceutical industry.
•Provide input into development of corporate compliance policies and procedures that reflect the needs of the affiliate. Work with leaders in the affiliate to develop and implement localized procedures. Ensure that these local procedures are consistent with global or business unit policies and procedures (or that any necessary exceptions are in place) and that they are effectively communicated to all impacted employees in the affiliate.
•Leverage AI, automation, and data analytics to generate valuable insights that catch risks early and prevent risks within areas of responsibility.

■Business Influence and Cross Function Collaboration
・Through deep business acumen and effective influence across different layers of the organization/leadership, ensure business discussions and decisions encompass and consistently take into consideration appropriate ethics and compliance elements, and that there is clear business ownership of ethics in all decisions taken.Influence leadership and business practices through effective communication of internal policies/standards and external environment risks.
•Ensure an open and collaborative environment that promotes teamwork, open
communication, and collaborative interactions to foster a culture of integrity.
•Orchestrate support from areas in Global Ethics and Compliance and other assurance functions.
•Collaborate with and influence Alliance Partner(s) to ensure high performance with high integrity in alliance settings in close partnership with business. Lead the compliance review and compliance agreement development for new business development deals.

求める経験 / スキル

【Basic Requirements】
・At least 3 years of experience within the pharmaceutical or related healthcare industry with knowledge of local laws, regulations, guidance and Codes.
・ Solid leadership experience
・Cross functional experience, experience to manage alliance situations preferred.
・Professional level proficiency in Japanese (speak, read and write) – preferably at the level to operate effectively with industry associations and regulators in Japan.
・Professional level proficiency in English to effectively collaborate with international E&C colleagues.
・ Bachelor's degree

【Additional Preferences】
・Demonstrated ability to consistently apply good judgement to enable quality business decisions.
・Ability to influence without authority and drive change across all layers of the organization.
・Strong strategic and critical thinking, with the ability to operationalize strategy and translate ambiguity and complexity into meaningful action.
・High proficiency in AI, automation, and data analytics, with the ability to analyze and visualize data for effective communication.
・Finance background preferred, with the ability to interpret financial data and follow financial flows.
・Strong business knowledge and results orientation.

勤務地

兵庫県

想定年収

972 万円 ~ 非公開

Marketing of Rare Tumors /Biopharma

メルクバイオファーマ株式会社

課長以上
外資系企業

仕事内容

■Position Summary
The Marketing Manager, Desmoid Tumor will lead market development, launch readiness, stakeholder engagement, and commercial execution for the first systemic therapy in Japan for patients with Desmoid Tumor.
The role is responsible for developing disease awareness, shaping treatment paradigms, building multidisciplinary treatment networks, partnering with patient advocacy organizations, and ensuring effective commercial execution.
This position combines Marketing, Market Development, Commercial Excellence, and Field Execution responsibilities and will play a critical role in transforming treatment practices and accelerating patient access.

■Key Responsibilities
Key Responsibilities
Brand Strategy & Launch Excellence
Develop and execute annual brand and market development strategies.
Lead launch readiness planning and execution.
Develop promotional materials, disease awareness programs, digital assets, and omnichannel campaigns.
Translate global strategy into actionable local initiatives.
Market Development & Ecosystem Building
Assess patient journey, referral pathways, diagnosis patterns, and treatment barriers.
Develop regional market development plans tailored to local market dynamics.
Build treatment ecosystems that facilitate diagnosis, referral, and treatment access.
Identify and address barriers to treatment adoption.
Stakeholder Engagement & Consensus Building
Establish and maintain relationships with key opinion leaders, treatment centers, and academic societies.
Partner closely with patient advocacy groups and patient communities.
Facilitate alignment among physicians involved in Desmoid Tumor management.
Support multidisciplinary treatment decision-making and referral networks.
Lead initiatives that drive consensus and behavior change across healthcare stakeholders.
Commercial Excellence & Field Execution
Develop field execution strategies and regional action plans.
Partner with Sales Leadership on territory prioritization and resource deployment.
Monitor execution quality and business performance.
Conduct regular business reviews and recommend corrective actions.
Ensure rapid translation of market insights into field actions.
Performance Management & Analytics
Develop KPIs and performance measurement frameworks.
Establish dashboards and business review processes.
Track customer engagement, referral generation, treatment adoption, and business performance.
Monitor launch performance and identify opportunities for optimization.
Support forecasting and business planning activities.

求める経験 / スキル

■Professional Experience
Minimum 5 years of pharmaceutical industry experience.
Proven marketing experience in Specialty Care, Oncology, Rare Disease, Immunology, or Hospital-based products.
Experience leading product launch or pre-launch activities.
Strong project management and cross-functional leadership skills.
Critical Experience
Demonstrated experience working across multiple medical specialties.
Proven ability to build alignment and consensus among healthcare professionals with different clinical perspectives.
Experience supporting multidisciplinary treatment decision-making processes.
Experience developing and executing market development initiatives.
Experience translating strategy into measurable field execution and business outcomes.
Experience developing KPIs, performance metrics, and execution tracking frameworks.

■Preferred Therapeutic Area Experience
Candidates should have meaningful experience in multiple of the following specialties:

Orthopedic Surgery
Gastrointestinal Surgery
Medical Oncology
Dermatology
Rare Diseases
Sarcoma or Tumor-related Diseases
Experience working across specialty boundaries and driving collaboration among different clinical stakeholders is strongly preferred.

従業員数

273名（メルクバイオファーマ（単体）2026年3月時点）

勤務地

東京都

想定年収

1,000 万円 ~ 1,400 万円

従業員数

273名（メルクバイオファーマ（単体）2026年3月時点）

National Account Manager

エランコジャパン株式会社

外資系企業

仕事内容

Functions, Duties, Tasks: 役割, 職責

動物病院を広域展開する企業本部との戦略的関係の構築・強化
全国の企業病院のマネジメント
製品の導入企業とのコミュニケーションおよび施策サポート
能力開発

求める経験 / スキル

Primary responsibilities
 企業動物病院本部へ様々な分野の製品を持つ組織の特長を生かし、その病院のニーズに合致した製品使用の提案し、本部担当者の信頼を獲得しながら製品の売上を最大化できる。
 企業動物病院の獣医師またはスタッフに適切なビジネス提案および情報提供を行い信頼獲得することで、良好な関係を築き同時に自社製品の売上を最大化できる。
 動物薬卸店の営業担当者と密接なコミュニケーションにより卸店から最大限の協力を得る。
Required Experience: (mandatory for hiring)
 小動物薬営業経験者（2年以上）
 様々な製品分野での販売経験
Desirable Experience:
 複数のエリアでの担当経験

Essential Skills / license: (mandatory for hiring)
 自動車普通免許
 高いコミュニケーションスキル

勤務地

東京都

想定年収

500 万円 ~ 非公開

テクニカルサービス

セバ・ジャパン株式会社

外資系企業

仕事内容

技術的エキスパートとして活動し、製品に関する質問や問題に対応し、顧客およびセールスチームをサポートし、自社製品の評価・満足度を高める。

求める経験 / スキル

【必須要件】
動物用医薬品メーカー、飼料メーカー等における養豚向けテクニカルサービス・技術営業の経験5年以上
養豚農場の飼養管理や疾病対策に関する知識

【歓迎要件】
資格：獣医師資格、HACCP・JGAP審査員資格
養豚農場での勤務経験

従業員数

30名（24年9月）

勤務地

神奈川県

想定年収

700 万円 ~ 非公開

従業員数

30名（24年9月）

Senior Manager, Learning Business Partner - Drug Development

ブリストル・マイヤーズスクイブ株式会社

課長以上
外資系企業

仕事内容

■Role Overview / Description
The Sr. Manager, Learning Business Partner (LBP) serves as the primary Drug Development learning partner and advisor for the Tokyo site — responsible for identifying capability needs, shaping the Drug Development site learning plan, and ensuring the effective delivery of aligned, high-impact learning solutions, including hands-on local delivery and facilitation where needed.

This role is part of a global R&D Learning team and plays a critical part in enabling Tokyo’s growth by translating enterprise learning strategy into localized, performance-driven capability building, addressing gaps in accessibility, localization, and application. In addition to site-facing responsibilities, the LBP works across Enterprise Learning, the LEAP Global Capability Center, APAC regional teams, and HR to implement scalable learning solutions, strengthen manager-led development, and support measurable performance outcomes

■Key Responsibilities
Site Partnership & Strategy (Drug Development)
・Partner with Tokyo Drug Development / R&D leaders to identify capability needs and learning priorities, aligned to business objectives, growth plans, and regulatory requirements
・Contribute to and execute the Drug Development site learning plan, translating enterprise and global DD priorities into localized, role-based learning solutions and experiences
・Build and manage a structured learning approach for the DD population at the site, including role-based pathways and integration of enterprise and local offerings

Local Delivery & Localization
・Facilitate and/or coordinate local facilitation of with SMEs, onboarding, skill development, enterprise and Drug Development programs at the site as required, including scheduling, hosting, and cohort-based session delivery
・Lead the localization of enterprise learning solutions, ensuring global programs are adapted for language, cultural context, and business relevance
・Support delivery logistics for enterprise-led leadership, skills, and functional programs run at or through the Tokyo site in partnership with the site learning lead

Global Team Contribution
・Partner with Enterprise Learning teams to align on enterprise programs (e.g., leadership, skills, compliance) and drive local pull-through, adoption, and relevance for the Tokyo population
・Operate as a member of the global R&D Learning team supporting broader learning initiatives and program beyond the Tokyo site as needed
・Establish and manage a site-level engagement model with the LEAP Global Capability Center (GCC) to support learning design, development, delivery, and measurement, with clear processes and prioritization

Regional & Cross-Site Alignment
・Engage with the APAC Regional Learning Lead to align on cross–Drug Development functional and site support, regional demand prioritization and LEAP intake, and regional programs and projects
・Contribute to APAC cohort-aligned delivery of regional programs, including potentially virtual facilitation and/or delivery that serves learners at other APAC sites
・Collaborate with APAC site Learning Business Partners, Site Learning Leads, and HR Business Partners to align approaches, share best practices, and ensure integration with broader talent and workforce priorities

Enablement & Effectiveness
・Manage Drug Development learning demand planning and prioritization for the site, surfacing aggregated demand into regional and LEAP intake
・Monitor learning effectiveness and gather feedback to continuously improve solutions, with a focus on increasing application and impact

求める経験 / スキル

■Key Capabilities / Skills
Strategic consulting & stakeholder influence
Learning strategy design and portfolio management
Facilitation and learning delivery, in person and virtual
Localization and cross-cultural learning expertise
Global operating mindset — comfort owning enterprise-level work and collaborating across time zones in a globally distributed team
Strong understanding of the R&D environment (e.g., regulatory, decision-making, scientific context)
Data-driven mindset with ability to link learning to outcomes
Strong collaboration across global and matrixed organizations

■Experience Requirements
Experience in Learning & Development, HR, or capability building
Experience partnering with senior leaders in a complex, global organization
Experience designing, implementing, and delivering learning strategies and large-scale programs, including direct facilitation
Experience working across global and local operating models preferred
Experience in a pharmaceutical / biotech / R&D environment preferred

従業員数

1,429名（※2025年6月時点）

勤務地

東京都

想定年収

1,000 万円 ~ 1,500 万円

従業員数

1,429名（※2025年6月時点）

Medical Advisor（感染症ワクチン領域）

大手外資製薬企業

外資系企業
上場企業

仕事内容

【職務概要】
■メディカルアドバイザーの主たる業務は、担当する疾患領域・製品に関するメディカルプランを作成し、メディカルプランで立案される各種メディカル活動を部門関係者やstakeholderとの協業のもと、実行することです。これらには、グローバル関係者とのコミュニケーションやコラボレーションも含まれます。そのため、メディカルアドバイザーには、担当疾患領域におけるハイレベルな科学的・医学的知識に加え、各ステークホルダーとのコミュニケーション能力、そしてメディカルプランを立案し遂行するための戦略的思考及び実行及びリーダーシップが求められます。

【主な業務】
■メディカル戦略
・担当する治療領域／製品において、フランチャイズ戦略と連携したメディカルプランを作成し、実行する。
・グローバルチームと連携し、グローバルメディカル戦略立案・実行について継続的に情報・意見を提供する。

■サイエンティフィックインサイト
・MSLマネージャーとの連携の下、MSLによるサイエンティフィックインサイト収集活動を管理し、収集されたサイエンティフィックインサイトを分析、メディカル活動に活用する。
・エキスパートインプットミーティングおよびその他のメディカルプログラムを企画・主導し、基礎研究及び臨床専門家から得られたサイエンティフィックインサイトをメディカル戦略に組み込む。

■メディカル教育プログラム
・担当疾患領域における教育アンメットニーズを特定し、フランチャイズ戦略と連携したメディカル教育プログラムを企画・実行する。

■Evidence Generation
・データニーズを抽出し、研究・調査をデザイン、立案、実行する。
・研究者主導研究に関して、SOPに沿って、フォローする。

■早期開発パイプライン品
・開発パイプライン品に関して、必要に応じて種々のメディカル情報の収集・解析・インプットを行う
・必要に応じて、開発品に関するサイエンス・メディカル面での戦略的な提言を行う

■社内業務
・MSLマネージャーと協力して、MSLチームメンバーやメディカルインフォメーションチームメンバーのスキル開発計画を設計および実行する。
・担当領域の販促資料を医学的・科学的観点からレビューする　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　
・担当疾患領域の専門家として、社内ステークホルダーに対して、科学・医学専門的な立場より必要なインプットを行う。

求める経験 / スキル

【必要な知識・スキル・コンピテンシー】
■Required（必須）
・医師、歯科医師、薬剤師、獣医師、薬学あるいは生命科学分野の博士号を有する（もしくは生命関連分野の修士号を有し、同分野の博士号の取得を計画している）。
・2年以上のヘルスケア分野における臨床・研究経験を有する。
・学術論文誌（査読あり）での論文発表経験、あるいは学会での発表経験を有する。
・国内における製薬企業に関連する規制、保険償還制度や臨床研究に関連するガイドライン等についての経験科学的データを深く理解することができ、高度な科学的バックグラウンドを有する。
・上位職位の指導／監督の元、研究のデザイン、立案、実行する能力を有する。
・チーム間の協力を促進する能力を有する。
・科学的専門知識によりサイエンティフィックリーダーとpeer-to-peerな関係を築く能力を有する。
・担当する疾患領域のチームをリードするリーダーシップを有する。
・言語：
日本語：ネイティブレベル
英語：グローバルチームとのコミュニケーションができるビジネスレベルの英語力（目安：TOEIC 860点以上相当の英語力）

■Preferred（尚可）
・2年以上のワクチン・感染症領域における臨床・研究経験
・ワクチン・感染症領域の専門医、PhD、MPH、ポスドク経験
・グローバル環境・海外での医療・研究経験

勤務地

東京都

想定年収

900 万円 ~ 1,500 万円

品質管理部長　＜秋田常駐／バイオ医薬品製造施設立上げ・品質管理統括＞

アルフェナックスバイオロジクス株式会社

部長以上

仕事内容

本ポジションは、新設されるバイオ医薬品製造施設において、品質管理部門をゼロから立ち上げる責任者です。
建設・立上げフェーズでは、発注者側の品質管理責任者として、試験設備・機器の立上げ、試験法運用設計、試験実施体制構築、試験結果検証といった品質管理業務の確立・整備を担っていただきます。また、工場稼働後は、品質管理部門責任者として、原材料試験、工程内試験、製品試験、環境モニタリング、安定性試験等を含む試験活動全般の責任を担っていただきます。
台湾CDMOの知見活用しながら、日本国内で新たなバイオ医薬品製造基盤を支える品質管理体制を構築する中核人材として、大きな裁量と責任を持って活躍いただけます。

・バイオ医薬品CDMO アルフェナックスバイオロジクスにおける新製バイオ医薬品製造施設において、品質管理部門責任者として、工場建設・試運転・試験体制構築・試験結果の検証・技術移管から、工場稼働後の品質管理業務まで一貫して推進する。
・バイオ医薬品の品質管理に関わる GMP 要件、試験法、試験設備・機器・要員、データ管理、外部委託業務等を理解し、エンジニアリング部門、コンサルタント、設計施工会社、試験ベンダー、品質保証部門、製造部門、台湾CDMO等との調整を主導する。
・試験に関わる設備・機器の立上げ、試験法の移管、試験実施体制の整備、品質支援員との稼働調整、品質管理業務の合理化および運用整備（試験計画、試験標準、試験運用、試験データ管理等）を行う。
・工場稼働後は、品質管理部門責任者として、原材料、工程内試験、製品試験、製造中試験、環境モニタリング、安定性試験等を含む試験活動全般の責任を負い、GMP に適合した品質管理活動を統括する。

求める経験 / スキル

【必須条件】
・医薬品 GMP に関する実務知識
・バイオ医薬品の品質管理に関する知識および品質管理責任者の経験
・GMP 工場における品質担当責任または品質管理マネジメントの実務経験
・試験設備・機器、試薬等、試験記録、試験結果、データインテグリティに関する基本的な理解
・複数の社外関係者（設計会社、施工会社、設備ベンダー、コンサルタント、外部試験機関、技術供与等）との調整・折衝経験
・品質管理部門または試験関連チームにおけるピープルマネジメント経験
・環境で発生する課題を整理し、関係者を巻き込みながら解決に導く能力
・秋田県内での常勤勤務が可能であること

【歓迎条件】
・バイオ医薬品、抗体医薬品、バイオシミラー等の品質管理経験
・新工場、新試運転室、または新規試験設備立上げの経験
・試験法移管、分析法バリデーション、分析技術レポリケーションの経験
・PMDA、FDA などの他国規制当局による GMP に関する試験対応の経験
・理化学試験、生化学試験、微生物試験、無菌試験、エンドトキシン試験、環境モニタリング等に関する知見または実務経験
・外部委託試験機関の選定、管理、監査経験
・LIMS、電子記録、試験データ管理、CSV、データインテグリティに関する知識または実務経験
・英語による技術文書・品質文書の読解、海外技術パートナーとのコミュニケーション経験
・台湾 CDMO 等、海外パートナーとの品質管理・技術移管プロジェクト経験

従業員数

1名

勤務地

秋田県

想定年収

1,000 万円 ~ 1,400 万円

従業員数

1名

製造部長　＜秋田常駐／バイオ医薬品製造施設立上げ・製造統括＞

アルフェナックスバイオロジクス株式会社

部長以上

仕事内容

本ポジションは、新たにされるバイオ医薬品製造施設において、製造部門をゼロから立ち上げる責任者です。
また、製造責任者としては、発注者側の製造責任者として、製造設備・機器の仕様確認、DQ/IQ/OQ/FAT/SAT、バリデーション、技術移管、製造文書整備、データ管理、品質部門との連携、運用フェーズへの移行を推進していく役割です。
工場稼働後は、安定生産の継続を目的に製造現場の運営を担っていただきます。
台灣CDMOの知見を活用しながら、日本国内で新たなバイオ医薬品製造基盤を形成していく中核人材として、大きな裁量と責任を持って活躍いただきます。

・バイオ医薬品CDMO アルフェナックスバイオロジクスにおける新製バイオ医薬品製造施設において、製造部門責任者として、工場建設・設備導入・試運転・立上げ後の工程を計画し、運営活動まで一貫して推進する。
・バイオ医薬品製造における GMP（適正製造基準）、製造プロセス、設備・機器整備を管理し、エンジニアリング部門、コンサルタント、設計・施工会社、CDMO関連の関係者、品質部門の連携を主導する。
・製造に関わる設備・機器・機能のDQ/IQ/OQ/FAT/SAT、バリデーション、技術移管、製造文書整備、データ管理等において、実行計画および進捗を管理し、品質・性能を確保する。
・上記で構築した製造設備・製造プロセスを確立し、製造開始後においても、製品・工程の品質維持に努める。

求める経験 / スキル

【必須条件】
・医薬品GMP およびバイオ医薬品製造に関する実務知識
・バイオ医薬品、抗体医薬品等の製造経験および製造責任者としての経験
・組織・監督、製造工程の主導が可能な経験
・GMP 工場における製造関連または製造品質に関する実務経験
・製造設備・機器、製造プロセス、製造文書、バリデーションに関する基本的な理解
・複数の社外関係者（設計会社、施工会社、設備ベンダー、コンサルタント、技術供与等）との調整・折衝が可能な経験
・製造部門または製造関連チームにおけるピープルマネジメント経験
・現場で発生する課題を整理し、関係者を巻き込みがが解決に導く能力
・秋田県内での常勤勤務が可能であること

【歓迎条件】
・新工場、新製造ライン、または新規設備立上げの経験
・技術移管、プロセスパラメータ設計、洗浄バリデーション、CSV 等に関する知識または実務経験
・PMDA、FDA などの他国規制当局により GMP 案査における製造現場対応の経験
・製造データ管理、電子記録、MES 等の製造関連システムに関する知識
・英語による技術文書の読解、海外技術パートナーとのコミュニケーション経験
・台湾 CDMO 等、海外パートナーとの製造・技術移管プロジェクト経験

従業員数

1名

勤務地

秋田県

想定年収

1,000 万円 ~ 1,400 万円

従業員数

1名

エンジニアリング責任者　＜新規合弁会社 / バイオ医薬品製造施設建設・立ち上げ・運営＞

アルフェナックスバイオロジクス株式会社

部長以上

仕事内容

＜概要＞
■新規合弁会社アルフェナックスバイロジクスにおける新設バイオ医薬品製造施設について、発注者側のエンジニアリング責任者として、計画、建設、試運転、立上げ、操業開始後の設備運営まで一貫して推進する。
■台湾CDMOが保有する技術・運用知見を理解し、設計・施工を担う大手建設会社、社内関係部門、各参画会社との技術的調整・合意形成を主導する。
■バイオ医薬品製造施設に求められる高度な技術・品質要求、GMP要件を踏まえ、設計・施工・コミッショニング・クオリフィケーションおよび安定操業体制の構築を支援する。
■海外パートナーの知見を活用し、日本国内で新たな生産基盤を形にしていく中核人材として、大きな裁量と責任を持ってプロジェクトをリードする。

＜主な職務内容＞
1. プロジェクト推進・関係者調整
・発注者側の現地エンジニアリング責任者として、建設プロジェクト全体の技術的調整・推進を担う。
・台湾CDMO、設計・施工会社、社内関係部門、各参画会社との間に立ち、要求仕様、設計意図、技術課題、変更事項を整理・調整する。
・台湾CDMOが有する工場をモデルとした施設計画について、技術移管・要求事項の理解、文書確認、質疑応答、意思決定支援を行う。
・工程、品質、コスト、リスクの観点から、プロジェクト進行上の課題を抽出し、解決を主導する。

2. 設計・建設フェーズにおける技術管理
・建築、機械、電気、計装、ユーティリティ、生産設備、クリーンルーム、GMP関連設備等について、現場での技術的整合を確認する。
・設計図書、施工計画、機器仕様、工程計画、バリデーション関連資料等のレビューおよび調整を行う。
・現場における施工状況を確認し、設計意図・要求仕様との整合性を管理する。
・変更管理、逸脱対応、是正措置、課題管理を実施し、関係者との合意形成を図る。
・試験、試運転、立上げに向けた準備を主導し、設備引渡しおよび受入れを支援する。

3. GMP・品質・立上げ対応
・バイオ医薬品製造施設として求められるGMP要件を踏まえ、設備・ユーティリティ・環境管理に関する技術的支援を行う。
・FAT、SAT、IQ、OQ、PQ、コミッショニング・クオリフィケーションに関係部門と連携して対応する。
・商業運転開始に向け、設備の安定稼働、保全体制、標準化文書整備、教育訓練の準備を推進する。

4. 操業開始後のエンジニアリング統括
・施設稼働後は、エンジニアリング責任者として設備・ユーティリティ・施設保全に関する統括業務を担う。
・設備保全計画、改善計画、更新計画、トラブル対応、外部ベンダー管理を主導する。
・生産・品質・保全・EHS等の関係部門と連携し、安定操業と継続的改善を推進する。
・将来的な増設、改造、能力増強、GMP監査対応等においても技術責任者として対応する。

5. その他
・上記に付随する、プロジェクト運営・設備運営上必要な業務。

求める経験 / スキル

【必須条件】
・工学系（機械、電気、化学、プロセス、建築設備等）のバックグラウンド、または同等の実務経験
・GMPにおける実務経験
・工場、プラント、医薬品・化学・食品・半導体等の高品質管理が求められる施設における、建設、設備導入、試運転、立上げ、保全のいずれかの実務経験
・複数の社外関係者（設計会社、施工会社、設備ベンダー、技術供与元等）との調整・折衝経験
・現場で課題を整理し、関係者を巻き込みながら解決に導く能力
・秋田県内での常駐勤務が可能であること

【歓迎条件】
・バイオ医薬品に関わる製造施設での業務経験
・cGMP、GMP、バリデーション、クリーンルーム、環境管理に関する知識または実務経験
・技術設備を伴う新工場建設、工場増設、設備更新プロジェクトの経験
・ユーティリティ設備（HVAC、PW、WFI、蒸気、圧縮空気、ガス、排水処理等）に関する知見
・英語による技術文書の読解、海外技術パートナーとのコミュニケーション経験
・発注者側またはCM/PMの立場でのプロジェクト推進経験

従業員数

1名

勤務地

秋田県

想定年収

1,000 万円 ~ 1,400 万円

従業員数

1名

Marketing & Communications Manager（希少疾患）

外資系製薬企業

課長以上
外資系企業

仕事内容

・製品戦略および中長期的なマーケティングプランの策定
・製品戦略に基づき、資材・イベント・デジタル施策の計画・実行
・KOLマネジメントの遂行
・領域の疾患啓発活動の統括
・関連する社内及び社外ステークホルダーと連携し、製品価値の最大化

求める経験 / スキル

・製薬業界でのマーケティング経験（3年以上）
・英語：ビジネスレベル

勤務地

東京都

想定年収

1,100 万円 ~ 1,400 万円

DX業務リーダー

第一三共株式会社

上場企業

仕事内容

治験薬供給のデジタルトランスフォーメーション推進
治験薬供給業務におけるDXリーダー
ERP 日本導入の協力

求める経験 / スキル

■必須
・治験薬供給業務あるいはそれに類する医薬品開発関連業務の経験を3年以上有し、AIを日常的に使用していること
・或いは、DX推進プロジェクト、AI導入プロジェクトなどをリードした経験を3年以上有すること
・失敗を次に活かせるマインドセット

■尚可
・ローコード開発、ノーコード開発の経験
・ITプロジェクトの経験者（例：ERPなどのシステム導入等）
・プロジェクトマネジメントの資格
・AI関連の資格

従業員数

20,171名（連結）

勤務地

東京都

想定年収

800 万円 ~ 1,400 万円

従業員数

20,171名（連結）

海外臨床開発責任者

株式会社Dioseve

仕事内容

当社はiPS 細胞を利用した生殖補助医療の開発に取り組む会社です。現在はiPS細胞から卵巣内細胞を分化誘導する技術を用いて、体外受精の成功率を大幅に向上させるだけでなく、投薬の負担を軽減させる治療法を開発しています。
現在臨床研究にフェーズが移行しており、今後はCDMO含め外部機関や規制当局とのやりとりが増加することが想定されます。そこで弊社としては現在、当社の細胞製品の開発を加速し、国内外の規制当局への申請を円滑に進めるため、臨床開発およびプロジェクトマネジメントを担う新たなメンバーを募集します。

求める経験 / スキル

【必須要件（以下すべて必要）】
・バイオ系大学修了
・企業経験15年以上
・医薬品、細胞製品、再生医療等製品での臨床開発またはプロジェクトマネジメントの経験（10年以上）
・GCPや各国の規制（PMDA、FDA、EMA など）に関する知識
・米国での経験またはFDAとの折衝経験（現地CROを介してでも可）
・プロジェクトマネジメントの基本的な知識とスキル
・優れたコミュニケーション能力および調整能力
・文書作成およびデータ管理能力
・英語での業務遂行能力（ビジネスレベル）

【歓迎要件】
・医薬品や再生医療等製品の申請経験及び承認取得経験（IND、BLA、NDA など）
・責任者としての上記の申請・承認経験
・PMDA、FDA などの規制当局との直接対応経験（特に直近での対応経験）
・グローバルな臨床開発経験
・PMP（Project Management Professional）などの資格保持者

従業員数

24名（2024年4月現在）

勤務地

東京都

想定年収

1,000 万円 ~ 1,600 万円

従業員数

24名（2024年4月現在）

メディシナルケミスト　～計算科学チームとの連携～

非公開

仕事内容

・共同研究や自社プロジェクトにおいて、計算技術を活用した創薬プロジェクトの推進
・メディシナルケミストとしての専門性を生かし、自社技術の開発・改善
・ケモインフォマティクスや構造活性相関（SAR）解析を活用した分子設計戦略の立案と実行

求める経験 / スキル

【必須（MUST）】
・製薬企業または創薬関連企業において、メディシナルケミストとしての創薬研究経験が7年以上ある方
・AIやシミュレーション技術の活用に理解があり、計算科学者と連携してプロジェクトを推進できる能力を有する方
・ケモインフォマティクスに関する基礎的な知識と実務スキルをお持ちの方
・薬学・理学・工学・生命科学など、関連分野における修士号以上の学位を取得されている方
・自ら課題を見つけ、関係者と連携しながら主体的に解決へ導ける方

【歓迎（WANT）】
以下のいずれかに該当する方は、特に歓迎いたします（すべてを満たす必要はありません）
・KNIMEを活用したデータ処理・ワークフロー構築の経験
・Pythonなどのプログラミング言語によるデータ解析・スクリプト作成スキル
・AI/機械学習に関する知識および創薬への応用経験
・MM・MD・QM/MM等の生体分子シミュレーション手法（例えばFEP等）の創薬への応用経験
・TPD（PROTACや分子接着剤など）やペプチドなどのモダリティに関する創薬経験
・創薬プロジェクトにおけるリーダー経験
・海外CROへの委託合成のマネジメント経験
・博士号取得者はより望ましい
・ビジネスレベルの英語力

【求める人物像】
・計算創薬に関して意欲的に取り組んでくださる方
・最先端の技術調査と議論を通じて研究を進める能力を持つ方
・チーム内外と友好的な協力関係を築き、効果的にコミュニケーションを取れる方

勤務地

東京都

想定年収

800 万円 ~ 1,500 万円

人事総務部長

日本ジェネリック株式会社

部長以上

仕事内容

親会社である日本調剤に投資ファンド（アドバンテッジパートナーズ／LYFE Capital）が参画し、
現在はグループ全体で中長期的な企業価値向上に向けた変革を推進しています。
特にジェネリック医薬品事業では、原薬内製化の推進など、製造体制の高度化・競争力強化に取り組む中での人事総務部門の責任者として
以下を担っていただきます。

■人事領域
人事制度（評価・報酬・等級）の見直しおよび運用高度化
要員計画／人員配置戦略の立案
採用戦略の設計・推進（特に製造・品質領域人材）
人材育成・組織開発施策の企画・実行
労務管理・コンプライアンス対応

■総務領域
総務機能全体の統括（規程、ファシリティ、リスク管理など）
管理部門としてのガバナンス強化

■経営連携
経営層と連動した組織・人材戦略の立案
事業成長に沿った組織体制の設計・改善
ファンド環境を踏まえたKPI・組織マネジメントの高度化

※日本ジェネリックの子会社「長生堂製薬」の人事総務部長も同時募集であり、採用確定まで同ポジションも兼務いただきます。
そのため同社拠点の徳島県徳島市でも定期的に出張いただきます。

＜魅力＞
・組織変革の中核を担うポジション
ファンド参画後の成長フェーズにあり、既存制度の運用ではなく
「組織を作る」人事に携わることができます。

・中長期の組織強化
ファンド傘下ではありますが、短期的なコスト削減のみを目的とするものではなく、
中長期的な事業価値向上を前提とした投資・組織強化が進められています。

◇グループ経営レベルの人事総務
親会社である日本調剤との連結対応や、投資ファンドが株主として参画していることにより、一般的な中堅企業では得られない高度な業務経験を積むことができます。

◇製造業界にありがちな堅苦しい雰囲気がなく挑戦と成長を歓迎する社風
「製薬は未知への挑戦」と考え、主体的に学び、責任感を持って行動する姿勢を大切にしています。

求める経験 / スキル

■必須要件
マネジメント経験（課長〜部長クラス）
人事制度／労務／採用いずれかにおける実務リード経験

■歓迎要件
製造業における人事経験
人事制度の企画・再設計経験
組織再編／要員最適化の経験
経営層との折衝・意思決定支援経験

■求める人物像
環境変化を前向きに捉え、主体的に組織を作れる方
現場と経営双方の視点を持ち、バランスよく判断できる方
数字やKPIをもとに人事施策を考えられる方
周囲を巻き込みながら変革を推進できる方

従業員数

557名（2025年4月1日現在）

勤務地

東京都

想定年収

1,200 万円 ~ 1,500 万円

従業員数

557名（2025年4月1日現在）

Compliance Director – Business Partnering & Advisory, Japan

グラクソ・スミスクライン株式会社

外資系企業
部長以上

仕事内容

Key Responsibilities
Act as the primary Compliance business partner and advisor to assigned Business Units and promoted brands, providing real-time, risk-informed guidance that enables faster launch, campaign and HCP-engagement decisions.

Embed Compliance early into brand strategy, business planning, speaker programs and promotional/information-provision activities, framing risk at the point of decision rather than after the fact.

Interpret and translate MHLW Guidelines, PMD Act advertising requirements, JPMA standards and GSK written standards into clear, practical business solutions and “how-to-comply” advice.

Partner with BU Heads, Marketing, Sales and Medical to evaluate risk appetite, identify proactive and pragmatic mitigations, and support well-documented, defensible business decisions.

Own and drive the local Risk Management & Compliance Board (RMCB) agenda for assigned areas, ensuring visibility, escalation and remediation of significant compliance risks to the Head of Japan Compliance and JLT.

Design, embed and continuously improve the Internal Control Framework for assigned BUs, emphasizing prevention — early-warning indicators, controls and capability-building over detection alone.

Lead root-cause analysis and CAPA for compliance issues in the business, ensuring accountable owners, due dates, evidence-based closure and effectiveness checks that withstand inspection.

Deliver targeted training, coaching and communications on the GSK Code of Conduct and key risks, building compliance capability and confident decision-making within the business.

Foster high ethical standards, Speak Up culture; promote transparency and psychological safety so employees raise concerns early, and handle sensitive matters with appropriate confidentiality.

Partner with Independent Business Monitoring, the Supervisory Division, Legal, HR and Investigations to align monitoring insights, feed lessons learned back into the business.

Breadth/ Scope of Accountability:

Japan-wide advisory accountability for assigned Business Units and promoted brands across the end-to-end commercial and information-provision lifecycle.

Works across Commercial, Medical, Material Excellence, Legal, HR, the Speaker Program CoE and enabling functions, while preserving Compliance’s independent challenge role.

Advises and influences without direct commercial ownership; business and functional leaders retain accountability for their activities, risks and controls.

Accountable for the quality, timeliness and defensibility of Compliance advice, RMCB inputs and CAPA discipline for the assigned portfolio.

Trusted with highly confidential and sensitive matters; expected to escalate significant risk without delay.

*Future scope of job and working location will be determined by company.

求める経験 / スキル

Knowledge/ Education/ Previous Experience Required:

A. Educational Background

Minimum Level of Education: Bachelor’s degree or equivalent practical experience
Area of Specialization: Law, Compliance, Life Sciences, Pharmacy, Business, Risk Management, or related discipline
Why is this level required: The role must interpret complex requirements, advise senior business leaders and translate regulation into practical, risk-based decisions.
Preferred Level of Education: Postgraduate qualification or relevant professional certification
Preferred Area of Specialization: Compliance, Legal, Regulatory, Business Administration, or Risk Management
Why preferred: Additional depth supports strategic business partnering, independent challenge and senior-level influence.

B. Job-Related Experience

Typically 8 or more years of relevant experience in pharmaceutical/healthcare compliance, ethics, legal, regulatory or risk management, including a track record of value-added business partnering. Equivalent depth may be considered.

Demonstrated ability to advise and influence senior commercial and medical leaders, balancing enablement of business performance with independent challenge.

Practical experience embedding internal control frameworks, running RMCB/governance processes and driving evidence-based CAPA and remediation.

People-management or team-leadership experience preferred; experience operating in a highly matrixed, multicultural organisation across geographies.

C. Other Job-Related Skills/ Background

Strong working knowledge of Japan pharmaceutical compliance expectations — MHLW Guideline for Product Information Provision Activities, PMD Act advertising requirements, JPMA standards and applicable GSK written standards.

Excellent business acumen and the ability to differentiate significant from less-significant risks and offer pragmatic, proactive mitigations.

Clear written and verbal communication in Japanese (native level) and English (business level); able to influence, coach and facilitate cross-functional discussions.

Strong problem-solving and conflict-management skills, learning agility, and the ability to maintain confidentiality, trust and independence.

Comfort with data, monitoring analytics and the responsible use of approved AI/digital tools to anticipate and prevent risk.

High integrity, sound judgement, courage to escalate, and a preventive mindset focused on effective controls rather than administrative burden.

*Legal right to work in Japan.

従業員数

2,500名（2025年1月時点）

勤務地

東京都

想定年収

1,000 万円 ~ 1,800 万円

従業員数

2,500名（2025年1月時点）

シニアブランドマネージャー

②外資スペシャリティーファーマ（神経・免疫領域）

課長以上
外資系企業

仕事内容

・製品戦略および中長期的なマーケティングプランの策定
・製品戦略に基づき、資材・イベント・デジタル施策の計画・実行
・KOLマネジメントの遂行
・領域の疾患啓発活動の統括
・関連する社内及び社外ステークホルダーと連携し、製品価値の最大化

求める経験 / スキル

・製薬業界での経験（5年以上）
・製薬業界でのマーケティング経験（3年以上）
・英語：中級ビジネスレベル

勤務地

東京都

想定年収

1,000 万円 ~ 1,450 万円

Vaccine Medical Manager

外資製薬企業

課長以上
外資系企業

仕事内容

Our Team:

The Japan Vaccine Medical Team is a high-performing team of medical leaders who are a trusted source of Scientific and Medical information and shared insights; effective and innovative strategic partners to our internal and external stakeholders; and dedicated to public health. We represent diverse experiences and backgrounds which strengthens our team and mirrors the healthcare communities we engage.

Main Responsibilities

The Japan vaccines Franchise Medical Manager will participate to and execute the Medical and scientific (non-promotional) strategy for the Influenza & Covid Vaccines portfolio/therapeutic area in close partnership with the other functional franchise leads and in alignment with the overall franchise strategy.

The Main Responsibilities Include

Utilize strong business acumen, acting as a key strategic business partner to the organization
Initiate and drive projects to raise standards of care and change clinical practice
Ability to work independently with a solutions-oriented and balanced approach to ambiguity
Lead and drive rapid integrated evidence planning and execution through deep understanding of internal and external stakeholder evidence needs and robust data gaps analysis
Deep therapy area expertise and product knowledge including competitor data
Drive strong collaborative relationships with commercial and cross-functional teams, including marketing, value & access, health economics, regulatory and clinical
Cultivate and maintain relationships with external experts
Drive collaborative relationships with above-country colleagues to ensure the MCO / country involvement and strategic input into global and regional plans
Good understanding of the impact and evolution of healthcare systems
Lead creation and implementation of medical plans
Ability to rapidly assimilate new data and integrate into new therapy area
Create industry leading digital educational and scientific content that is timely, relevant, interactive and innovative
Champion the patient voice when developing and implementing medical strategies
Demonstrate strong leadership influencing across networks and by coaching and mentoring members of the team

求める経験 / スキル

Education/Experience/Certification

About you

Doctorate level education: MD or equivalent medical degree preferred, PhD or PharmD
Industry experience (including medical affairs field or office) and/or clinical experience mandatory, ideally with relevant immunology, vaccinology, epidemiology, public health or internal medicine focus on acute medicine/ICU experience.
Good understanding of the continuum of data generation including clinical development, Real World Evidence (RWE) and data gaps analysis
Excellent communication skills including driving challenging discussions· Develop a good understanding of HCP communication preferences to adapt communication style and optimize use of relevant channels to suit
Implement true scientific engagement journeys by bridging channel disconnect to drive ongoing engagement and grow collaborative opportunities and meaningful scientific exchange
Be confident in the use of Omnichannel tools and ability to adapt to new channels
Effectively and compliantly share unmet needs of HCPs and their centers with cross-functional teams to inform patient centric strategy

勤務地

東京都

想定年収

1,400 万円 ~ 1,850 万円

パブリック・アフェアーズ（広報）アソシエイト・ディレクター

大手外資系製薬メーカー

外資系企業
部長以上

仕事内容

・医療・ヘルスケア領域における広報・渉外戦略の立案および実行
・患者団体、医療関係者、メディアとの関係構築・コミュニケーション推進
・疾患啓発活動やアドボカシープログラムの企画・運営
・グローバルおよび国内関連部門と連携した企業・ブランド認知向上施策の推進
・社会的意義の高い革新的な医療ソリューションの普及と認知向上

求める経験 / スキル

■応募要件
・製薬・ヘルスケア業界における広報・コミュニケーション領域の実務経験
・メディアリレーション、コーポレートコミュニケーション、危機管理広報の経験
・医科学情報をわかりやすく社内外へ発信できる高いコミュニケーション力
・マーケティング、メディカル、渉外部門など関係部署との協業経験
・ビジネスレベルの英語力
・製薬業界における広報・広告関連規制への理解
・プロジェクトや予算、エージェンシーのマネジメント経験
・ヘルスケア政策に関する知見をお持ちの方歓迎

■求める人物像
・多様なステークホルダーと良好な関係を構築
・周囲を巻き込みながら成果を創出できる方
・学習意欲が高く、新しい領域や変化に柔軟に対応できる方
・変化の多い環境においても前向きに課題解決へ取り組める方
・優先順位を適切に判断し、主体的に業務を推進できる方
・高い品質と成果にこだわりながら業務を遂行できる方

勤務地

東京都

想定年収

1,050 万円 ~ 1,500 万円

Medical Affairs TA Head

外資製薬企業

外資系企業
部長以上

仕事内容

【About the job】

The Respiratory and Rhinology Medical Head drives clarity and accountability of the entire Japan medical functions and cross-functional team members, to achieve the business objectives through the development and execution of medical strategies.
Reporting to the Japan Head of Specialty Care Medical, and involved in development of the strategic medical plan, the Respiratory and Rhinology Medical Head ensures the execution of key deliverable, conducts timely analyses, and provides updates, utilizing clear and consistent communication.
The role leads the teams to improve operations effectiveness and to execute key projects, while serving as the medical point of contact for alliances.

【Key Responsibility】
Develop Respiratory and Rhinology therapeutic area plans for Alliance immunology products:
Oversee the development of medical strategies and timelines for key product-specific cross-functional projects (eg Product Ad Boards, LCM activities related to Phase IV, and Investigator initiated studies and other cross functional initiatives led by Medical)
Provide input during the development of global product plans regarding publications, training initiatives, KOL planning and metrics, etc
Collaborate with regional medical contacts to align on the global plan and exchange information on global/local medical activities, strategies and tactics
Work with the team to identify risks to the programs and develop mitigation steps for them

Communicate appropriate and timely program information to key functions:
Work with the team to identify risks to the programs and develop mitigation steps for them

Execute Respiratory and Rhinology MedicaI Therapeutic Area Plans:
Lead strategic financial trajectory, Annual 0perating Planning activities as well as forecast resources in conjunction with Global Medical Director, global medical functions and Commercial partners, for proposed tactics, research initiatives, publications, advisory boards, medical training, medical information, and personnel, etc
Lead Local Respiratory and Rhinology medical team and related meetings by proactively identifying agenda items, assimilating appropriate meeting content, facilitating alignment, and ensuring appropriate follow-through
Partner with global medical functional leads regarding functional product plans to ensure product- team alignment and timely execution
Drive and implement best practices through the creation of processes, tools and templates (ie Product team list with roles and responsibilities, product resources list, etc)

Plan and track key milestones and report progress of Medical plans
Facilitate prioritization of activities within Medical plans
Provide input into infrastructure improvement initiatives (eg. Operational, technical etc)
Serve as contact for worldwide affiliate regarding meeting content development for the product
Supervise and coach MSL managers towards the identification, mapping and quarterly review of KOLs to develop and maintain customized engagement plans,
Monitor and supervise MSL Managers’ execution of plans with their respective teams and with prioritized KOLs via regular coaching sessions
Manage and meet reporting requirements of MSL performance including supervising the MSL managers monitoring metrics towards set KPIs ensuring excellence in execution of their role towards achieving strategic and tactical goats.

求める経験 / スキル

Education, Experience & knowledge:
MD in Internal medicine and/or advanced degree (PhD) in life sciences preferred
Strong verbal and written communication skills in both English and Japanese.
Minimum of 5 years of related industry experience
Prior experience conducting strategic planning activities, leading cross-functional teams at different levels, as well as a solid understanding of a Global Medical Affairs and R&D environment and pharmaceutical commercialization and regulatory processes are highly preferred
Able to operate independently (with minimal supervision) and navigate complex regulatory environments in person and via digital channels from remote (non-office based) environment.
Possible substantial travel: nationally and internationally
Ensures regulatory boundaries re non-promotional activities are respected vis-a-vis commercial partners.

Key skills:
Ability to cultivate solid internal and external network
Excellent interpersonal skills/highly collaborative
Strong facilitative leadership skills: ability to drive consensus across diverse functional groups
Excellent analytical and problem- solving skills
Strong financial and operational skills: project/timeline management
Sound scientific/technical and business acumen
External consultant and vendor management

勤務地

東京都

想定年収

1,870 万円 ~ 非公開

[Pfizer] Senior Manager for Policy:4963413

ファイザー株式会社

課長以上
外資系企業

仕事内容

Role Summary

The Senior Manager, Policy plays a pivotal role in advancing Pfizer’s policy strategy and initiatives in Japan, aligning with the company’s purpose of delivering breakthroughs that change patients' lives and its business priorities in Japan. This strategic, externally oriented position requires strong commercial acumen and broad stakeholder engagement, serving as a key liaison between Pfizer and external stakeholders, including policymakers, industry associations, and other thought leaders, to drive impactful policy programs.

As part of the International Policy and Communications (IPC), the role collaborates closely with the other IPC functions, Communications and Community Engagement, as well as with other internal partners and external stakeholders, both in Japan and globally, to enhance policy impact and operational efficiency.

Role Responsibilities

Develop and implement external stakeholder engagement strategies, fostering trusted relationships with policymakers (including Diet members, central and local government officials) as well as key influencers such as academics and think tanks.
Provide strategic policy support to advance business objectives, driving internal and external initiatives aligned with relevant therapeutic areas and policy domains.
Monitor and analyze political, legislative, and healthcare policy developments, providing timely strategic advice to senior leaders and proactively addressing risks and opportunities affecting Pfizer’s business, reputation, and market access in Japan.
Develop and implement strategic projects, ensuring clear and effective communication of the company’s priorities and policy positions.
Collaborate across all business units to design and articulate impactful policy frameworks, delivering strategic initiatives that address key policy priorities in Japan.
Influence policy-making by raising public awareness and partnering with third-party organizations, in coordination with the Communications and Community Engagement teams.
Develop clear, evidence-based policy positions, briefing materials, and other external-facing content to support policy development and advocacy.
Represent the company’s interests and perspectives in industry association policy activities.

求める経験 / スキル

Qualifications

Bachelor’s degree or equivalent relevant professional experience.
Professional-level fluency in Japanese and English, with excellent written and verbal communication skills in both languages. The role requires the ability to engage external stakeholders in Japanese and work effectively with global colleagues in English.
Highly motivated, able to work collaboratively and creatively to solve problems.
Strong self-management skills; able to work autonomously and proactively.
Typically, 8 or more years of relevant experience.
In-depth understanding of the policymaking process, including legislative procedures and regulatory frameworks.
Strong grasp of the interplay between government, politics, and business, enabling effective navigation of complex stakeholder dynamics.
Demonstrated ability to build and maintain trusted relationships with government officials, policymakers, industry representatives, and other influential stakeholders. An established relevant network is highly desirable.
Ability to coordinate and negotiate with a wide range of stakeholders on important, high-impact issues.

Good understanding of Japan’s healthcare policy environment, including the National Health Insurance system, drug pricing and reimbursement, health technology assessment, medicines regulation, and market access policy.
Established trust with key stakeholders.
Effective collaboration skills with third-party organizations such as patient groups and non-governmental organizations.
Strong project management skills, including planning and prioritization for cross-departmental initiatives.

従業員数

2,700名（(2026年6月現在 )）

勤務地

東京都

想定年収

800 万円 ~ 1,600 万円

従業員数

2,700名（(2026年6月現在 )）

グローバルQA企画リード

第一三共株式会社

上場企業

仕事内容

●グローバルQAの中核メンバーとして、中長期の品質保証戦略を策定
●策定された中期経営計画に基づきモニタリング及びマネジメントを行い、品質保証組織の強化・最適化を推進
●グローバル規模での品質保証に関わる新規プロジェクトや施策の立案から実行までをリード
●国内外のグループ会社や関連部門と連携し、横断的な課題解決やプロセス改革を推進
●経営層やステークホルダーと緊密に連携し、戦略に沿った品質保証体制の構築に貢献

≪入社後のキャリアパス≫
●グローバルQA組織における中期経営計画・年度業績目標の立案や、プロジェクトのリードを担当し、QA企画職のリーダーへの育成
●強みと適性を見据え、主要QA機能のGlobal Lead/Head、海外駐在、幹部職への登用、薬事・サプライチェーン等の他部門への活躍の場への発展

求める経験 / スキル

■経験スキル〈必須〉
●製薬企業でのGXP*-QAまたはGXP*業務の経験
（*GXP:GMP,GCP,GLP,CSPV,MA,GQP等）もしくは製品開発、臨床開発を通じてGXP業務に対する理解があるもの
●グローバル・他部所・他社を巻き込んだ新規検討案件や改善案件の施策立案及びプロジェクトリードの経験　
●英語力（英語での会議において、適切に応答し、自分の発言が理解・納得されるレベル）
●グローバルな環境（多様性のある環境）で一定のリーダーシップを発揮し、価値創造を行った経験

■経験スキル〈尚可〉
●ITツールの開発もしくはAI等の活用による業務効率改善の経験
●コミュニケーション能力、対人折衝力、協調性、積極性、課題突破力、誠実さ
●文章作成能力、パワーポイント等を用いた可視化能力

従業員数

20,171名（連結）

勤務地

東京都

想定年収

800 万円 ~ 1,400 万円

従業員数

20,171名（連結）

＜倫理・コンプライアンス本部＞Ethics & Compliance/Senior Director/神戸本社

日本イーライリリー株式会社

外資系企業
部長以上

仕事内容

Serve as a strategic business partner to senior leadership, leading Ethics & Compliance initiatives that enable sustainable business growth while maintaining Lilly’s high standards of integrity and governance.

Partner with cross-functional teams and global stakeholders to identify, assess, and mitigate compliance risks, while embedding ethical decision-making and a strong culture of accountability across the organization.

Play a key role in supporting new business initiatives, digital innovation, and strategic partnerships by providing compliance leadership, influencing critical decisions, and driving organizational change and capability development.

求める経験 / スキル

■Required Experience / Skills / Qualifications
Bachelor’s degree or higher.
Minimum of 5 years’ experience within the pharmaceutical, biotechnology, healthcare, or related industry.
Working knowledge of applicable healthcare laws, regulations, industry codes, and compliance requirements.
Strong cross-functional collaboration experience, with the ability to partner effectively across business functions and stakeholder groups.
Professional-level fluency in Japanese and business proficiency in English, with the ability to operate effectively in a global environment.
Demonstrated integrity, sound judgment, and a strong commitment to ethical business practices.

■Preferred Qualifications
Experience in Compliance, Legal, Risk Management, Internal Audit, or other governance-related functions.
Leadership experience within commercial, sales, or business operations organizations.
Experience supporting alliance partnerships, brand teams, or new business initiatives.
Proven ability to influence senior stakeholders and drive decisions without direct authority.
Strong strategic thinking, problem-solving, and change management capabilities.
Ability to translate complex and ambiguous situations into clear, actionable business solutions.
Strong business acumen with an enterprise-wide perspective.
Inclusive leadership style with a passion for coaching, mentoring, and developing talent.
High level of professional maturity, discretion, and confidentiality.
JD, CPA, or equivalent professional qualification is a plus.

従業員数

2,750名（2025年末現在）

勤務地

兵庫県

想定年収

972 万円 ~ 非公開

従業員数

2,750名（2025年末現在）

[Pfizer] Senior Manager, Business Development

ファイザー株式会社

課長以上
外資系企業

仕事内容

■In this role, you will:

Independently identify, evaluate, and drive new business opportunities including partnerships, licensing (in/out), acquisitions, and divestitures.
Lead end-to-end deal processes including evaluation, valuation, negotiation, due diligence, contracting, and post-deal alliance management.
Partner closely with cross-functional teams to assess strategic fit, feasibility, and business rationale.
Monitor industry trends, competitive activity, and market dynamics to inform BD strategy and opportunity creation.
Manage multiple BD projects concurrently with high autonomy in a fast-paced, lean organizational setting.
Represent Pfizer as a credible counterpart in external partner discussions and negotiations.
Support the BD Lead in shaping and executing Pfizer Japan’s BD strategy and long-term growth initiatives.

求める経験 / スキル

■Here Is What You Need (Minimum Requirements)

Bachelor’s degree in business, life sciences, or a related field.
Minimum 5 years of experience in business development in the pharmaceutical/biotech industry.
Proven track record of independently leading BD deals through successful closure.
Strong analytical, communication, and negotiation skills.
Experience working cross-functionally.
Deep understanding of the Japanese pharmaceutical industry and regulatory environment.
Solid understanding of deal structures, contracts, and negotiations.
Fluency in both Japanese and English.
High sense of confidentiality and ethics.

■Bonus Points If You Have (Preferred Requirements)

MBA or advanced degree.
Experience working in a global matrix organization.
Experience in alliance management or post-deal integration.
Strong project management and problem-solving capabilities.
Flexibility, adaptability, and ability to manage ambiguity.
Proven ability to engage directly and effectively with senior stakeholders, both internally and externally.

従業員数

2,700名（(2026年6月現在 )）

勤務地

東京都

想定年収

1,000 万円 ~ 1,500 万円

従業員数

2,700名（(2026年6月現在 )）

APAC Compliance Manager

グローバル製薬企業

外資系企業
部長以上

仕事内容

【ポジション概要】
グローバルに事業を展開する製薬・ヘルスケア関連企業において、APAC地域（主に日本・オーストラリア）を担当するコンプライアンスマネージャーポジションです。
グローバルコンプライアンス部門に所属し、日本法人の経営陣とも連携しながら、APAC地域におけるコンプライアンスプログラムの運営・推進を担当いただきます。日常的なビジネス支援に加え、医療従事者（HCP）対応に関する審査・承認、ポリシー整備、教育研修、内部調査、リスク評価およびモニタリング活動など、幅広い業務を担います。
営業、メディカル、法務、薬事、内部監査などの関連部署や海外チームと連携しながら、コンプライアンス体制の強化と企業倫理文化の浸透を推進していただくポジションです。

【主な業務内容】
■コンプライアンス業務全般
・医療従事者との契約・講演依頼・学会協賛等のレビューおよび承認
・経営層向けのコンプライアンス関連レポート作成
・グローバルコンプライアンスチームとの定例ミーティングへの参加
・APAC地域における法規制や業界動向のモニタリングおよびリスク分析
・海外拠点経営陣との定期的なコミュニケーション
・贈収賄防止・腐敗防止に関する第三者デューデリジェンスの実施

■メディカル・コマーシャル領域のコンプライアンス支援
・MR・MSLによる情報提供活動に関するアドバイス
・販促資材、メディカル資材、講演会資料等のコンプライアンスレビュー
・外部モニタリングに関する委員会対応および関連資料作成

■ポリシー整備・教育研修
・APAC地域のコンプライアンス関連規程やガイドラインの整備・改訂
・社内からの問い合わせ対応
・年間コンプライアンストレーニング計画の策定
・教育研修および社内啓発施策の企画・運営
・新入社員研修や営業・代理店向け研修の実施
・コンプライアンス関連資料や教育コンテンツのローカライズ支援

■調査・リスクマネジメント
・内部通報案件やコンプライアンス事案の調査対応
・関係者ヒアリング、調査報告書作成、是正措置の推進
・人事部門と連携した再発防止策や指導対応
・監査・モニタリング活動を活用したリスク低減施策の推進

■コンプライアンス監査・モニタリング
・APAC地域におけるコンプライアンスリスクアセスメントの実施
・年間監査・モニタリング計画の策定および実行
・講演会、販促活動、営業同行、各種記録類のモニタリング
・グローバル本社への定期レポーティング
・モニタリング結果を踏まえた業務改善・プロセス改善の推進

【ポジションの特徴】
・APAC地域を担当するリージョナルポジション
・日本・海外双方のステークホルダーと連携するグローバルな環境
・HCP対応、販促審査、教育研修、内部調査、監査・モニタリングまで幅広いコンプライアンス業務に関与可能
・経営層や海外本社との接点が多く、事業に近い立場でコンプライアンス推進を担えるポジション
・製薬・ヘルスケア業界における高度なコンプライアンス経験を積むことができる環境

求める経験 / スキル

• 5 years minimum industry experience, 2 years compliance or related experience
• In-depth knowledge of the industry’s standards and regulations related to compliance with healthcare laws
• Able to work independently and know when to appropriately escalate an issue for resolution
• Capacity of problem solving - anticipating, initiating and resolving issues
• Demonstrated ability to communicate effectively with individuals up, down, and across the organization
• Excellent technical and communication skills
• Fluent in Japanese and English

勤務地

東京都

想定年収

715 万円 ~ 1,872 万円

ADME研究チームリーダー／プリンシパルADMEサイエンティスト

第一三共株式会社

上場企業

仕事内容

【職務内容】
・自身およびチームが担当する研究の戦略および研究計画の策定
・組織横断的なチーム研究のリード
・候補品創出や開発判断への提案
・技術開発、申請対応および研究環境整備の主導
・研究員の指導・育成・監督
・所内外連携の構築

【入社後のキャリアパス】
・R5(ディレクター):薬物動態研究のスペシャリスト

求める経験 / スキル

＜必須＞
・非臨床薬物動態研究の実務経験(目安：７年以上)
・チームリーダーの経験
・課題設定力
・研究計画策定力
・組織横断的な研究リーダーシップ
・他部署との連携構築力

＜尚可＞
・外部組織との協業を円滑にリード、推進した経験　
・国内外の外部研究者との幅広いネットワークを構築した経験
・留学経験
・英語中級以上
・理系博士号取得者

従業員数

20,171名（連結）

勤務地

東京都

想定年収

800 万円 ~ 1,400 万円

従業員数

20,171名（連結）

非臨床Modeling and Simulation担当者

第一三共株式会社

上場企業

仕事内容

【職務内容】
・非臨床モデリング＆シミュレーション戦略策定
・探索段階のテーマについてモデリング＆シミュレーション計画の策定
・モデリング＆シミュレーションの実行
・候補品創出や開発判断への提案
・新規解析手法の導入
・チーム研究のリード
・所内外連携の構築

【入社後のキャリアパス】
・R5(ディレクター):非臨床M&Sのスペシャリスト
・R6(シニアディレクター):臨床開発全体のM&Sを考慮した非臨床M＆Sファンクションリーダー
・臨床M&Sチームへの異動を通じたキャリア形成

求める経験 / スキル

＜必須＞
・非臨床PK/PD、PBPK、　pharmacometricsモデリングの実務経験(5年以上)
・チームリーダーの経験
・課題設定力
・研究計画策定力
・非臨床モデリング＆シミュレーションスキル
・チームリーダーシップ
・連携構築力

＜尚可＞
・外部組織との協業を円滑にリード、推進した経験　
・国内外の外部研究者との幅広いネットワークを構築した経験
・留学経験
・英語中級以上
・理系博士号取得者
・データサイエンスに関する資格

従業員数

20,171名（連結）

勤務地

東京都

想定年収

800 万円 ~ 1,400 万円

従業員数

20,171名（連結）

[Innovative Medicine] R＆D, Principal Scientist, CMC Group, CMC Sciences, Regulatory Affairs R-099692

ヤンセンファーマ株式会社

課長以上
外資系企業
在宅勤務可

仕事内容

Job Description:
Position Summary
To prepare application dossiers for CMC part and to communicate with HA appropriately to contribute in obtaining regulatory approval.

To conduct change control of approved products appropriately.

Specific Tasks and Job Duties

・Manage Team management
Fulfill CMC-RA responsibilities at team meetings and contribute to compound development / product lifecycle management
Supervises members, manage resources and timelines to deliver activities on schedule.

・CMC-RA strategy planning / alignment
Identifies and inputs relevant Japan CMC regulatory information required to develop global CMC-RA strategy at the project initiation.
Develop Japan CMC-RA NDA strategy
Align to the product’s global post-marketing regulatory strategy.

・CMC dossier management
Creates pre- / post- approval CMC dossiers including consultation documents.
Ensure regulatory document compliance through appropriate document preparation including accurate writing, review, QC, and compliance checks.
Reviews CMC documents prepared by team members and provides valuable input.

・Implement regulatory procedures
Prepares and answers to CMC questions from PMDA, and communicate directly with PMDA officials where necessary.
Handles change control of approved products
Copes with GMP / compliance inspection by PMDA

・Management of regulatory changes in Japan
Assesses the impact of new / revised CMC regulations and implements necessary changes

・Contribute through task force / external activities
Participates in task forces/initiatives, collaborating with team members, as well as global and cross functional stakeholders to achieve continuous improvement.
Participates in external events or industry activities and makes a positive impact.

求める経験 / スキル

Minimum Qualification
Experience/Knowledge
At least 7 years’ experience in CMC related area in pharmaceutical industry
Familiar with CMC regulatory notifications in Japan
Experience of completing NDAs in Japan either independently as a CMC-RA representative or as a team leader or Experience in regulatory procedures in pharmaceutical research / CMC-related operations

・Skills/Capabilities
Ability to discuss CMC regulatory topics with global members in English
Able to build trust with others including global members and government
Able to respect others and appropriately discuss and build consensus with team members
Adaptability to IT/DX

Qualification/Certificate
Bachelor, Master, Doctor of Science degree

従業員数

2,000名（2025年7月1日現在）

勤務地

東京都

想定年収

1,100 万円 ~ 1,500 万円

従業員数

2,000名（2025年7月1日現在）

Manager, Japan Country Quality

アレクシオンファーマ合同会社

課長以上
外資系企業
上場企業

仕事内容

This is what you will do:
【Manager, Japan Country Quality】
製造販売業者の信頼性保証部員として、当該役職者はGlobal AlxionのポリシーおよびSOPに従い、GQP QAグループを管理する。また、QMS管理業務、APJ手順書作成/制定、各品質協定規格締結/遵守、GMPコンプライアンス調査、製造所認定業務などの主要な活動を通じて、適正品質管理（GQP）およびGMDPの準拠を確保することを主たる責務とする。さらにAPJが製造販売業者として顧客クレーム対応も管理する。そのために社内外顧客、即ち、安全性管理部門、サプライチェーン、メディカル、薬事、CMC、営業・マーケティングなどと部門横断的に協働し、所轄当局や共同販売会社と連携・調整を行う。

You will be responsible for:
・開発品から市販後製品としてのGMDP/GQPプロセスのコンプライアンス管理
市販後製品の品質管理システム管理
製造販売業体制管理/主に品責・総責のサポート業務
市販後製品の品質関連業務

You will need to have:
・各種プロジェクト会議を主宰しリードする
QA週例会議において、担当業務におけるトピックを速やかに報告する。
QA月例会議において、品質関連情報のトレンド分析を行い、必要な場合と是正を推進する。
QMS会議/主に変更・逸脱会議/事案に対する対応方針などの検討する
Global組織とのコミュニケーション多数に参加し、APJの情報を報告・協議する。

求める経験 / スキル

We would prefer for you to have:
・Bachelor’s degree plus more than 5 years-experience in pharma or bio industry
・CMC and QA/QC related technical experiences (manufacturing, analytical)
・Knowledge of JPAL/ GQP/ GMP requirements
・Expert of Quality Management System
・Project Management skill (planning, problem solving)

・Communication skill
・Negotiation skill
・Facilitation skill
・Problem solving skill
・Leadership Capabilities

■■バックグラウンドチェック、リファレンスチェックの実施について■■
バックグラウンドチェック、リファレンスチェックが選考過程に含まれます。
実施前には候補者様にご案内、ご同意いただいた上で、原則最終面接実施確定以降に実施されます。（詳細はコンサルタントよりご説明いたします）

勤務地

東京都

想定年収

1,200 万円 ~ 1,550 万円

Senior MSL

ヴィーブヘルスケア株式会社

課長以上
外資系企業

仕事内容

Job Purpose:

The Senior Medical Science Liaison (Sr. MSL) is a field-based scientific expert with in-depth knowledge of ViiV medicines and relevant therapeutic areas. The Sr. MSL provides non-promotional scientific engagement with HCPs to ensure the safe and appropriate use of ViiV products and uses information gathered during these interactions to contribute to improving the quality of medical care and maximizing patient benefits. In addition to core MSL responsibilities, the Sr. MSL acts as a field leader and role model for the MSL team, leads field activities, coaches team members, and drives organizational medical strategy.

Key Responsibilities:

Lead and contribute to the planning and execution of tailored engagement strategies with stakeholders

Conduct scientific engagements with HCPs (1:1 and group settings) based on pre-planned and on-request interactions

Leverage digital tools and omnichannel approaches to optimize stakeholder engagement

Share insights within Medical Affairs, across global teams, and with other cross-functional teams

Support (organize as needed) Medical Affairs events, advisory boards, scientific workshops, and symposia

Provide speaker training for paid speaker events

Coach and mentor MSL team members to maximize the quality and quantity of field activities

求める経験 / スキル

必要な条件　Basic Qualification

スキル Skills

Ability to work in a high-performing team and with multiple stakeholders, both internally and externally.

Strategic thinker with leadership skills

Resilient self-starter who can act independently and learn quickly

経験　Experience

Demonstrates ethical conduct and accountability for impact

At least three years of experience as an MSL or in an equivalent role within the industry

学位/資格/語学力　Education/certification/Language

Fluent written and verbal communication skills in Japanese

Business-level written and verbal communication skills in English

望ましい条件　Preferred Qualification

スキル Skills

Perceptive, creative, and proactive, with the ability to contribute new ideas and build consensus

経験　Experience

Acts as a change agent, fostering innovation and collaboration

Strong scientific knowledge and insight in HIV/Virology/Infectious Diseases

学位/資格/語学力　Education/certification/Language

Master’s degree or PhD in science, and/or qualification as a Pharmacist or MD

従業員数

50名（2022年11月現在）

勤務地

東京都

想定年収

1,000 万円 ~ 1,400 万円

従業員数

50名（2022年11月現在）

Engagement and Innovation Lead/Manager/Global ExpMED Inflammation

日本ベーリンガーインゲルハイム株式会社

課長以上
外資系企業

仕事内容

■Basic Purpose of the Job
The Clinical Program Leader assumes Clinical Development responsibilities supporting early or late development projects, reporting to the Associate Global Head or the Global Clinical Programme Team Leader.

The Clinical Program Leader has a medical leadership role for a project or a portion of a project in clinical development, usually at Start of Development through Phase I–III.

The Clinical Program Leader provides medical/scientific, technical, and managerial direction to plans, programs, and procedures within project and indication areas to effectively develop new compounds and/or optimize the profile of existing compounds.

The Clinical Program Leader in Experimental Medicine Japan assumes responsibility for engaging External Experts (EEs) in Japan. A core element of this role is identifying and engaging experts with expertise in:
・Early clinical development
・Translational science
・Advanced modalities within the therapeutic area
and leveraging their scientific and operational insights to inform global early clinical development strategy.

■Accountabilities
Clinical Development Leadership
Represents the specific Therapeutic Area on International Multidisciplinary Core Teams and takes clinical development responsibility for assigned projects, including:

・Definition of Target Product Profiles (TPP)
・Clinical Development Plans (CDP)
・Pediatric Investigational Plans (PIP)
・Core Clinical Trial Protocols
・Input to Project Analysis and Data Management Plans
・Investigator's Brochure
・Medical input to Company Core Data Sheet
・Annual Safety Reports / IND Safety Reports
・Preparation for key milestones:
　　・Start of Development
　　・Proof of Clinical Principle (PoCP)
　　・Release of Full Development

■Related Performance Indicators
・Provides medical oversight throughout protocol development, study conduct, analysis, and reporting.
・Responsible for continuous benefit-risk assessment.
・Provides medical leadership during regulatory meetings.
・Contributes to submission strategy and regulatory filings.
・Addresses safety issues.
・Oversees medical project budgets.

■Cross-Functional Team Leadership
Serves as Chairperson of the Global Early Clinical Development (ECD) Team and/or Medical Sub-Team (MST), depending on project stage.

Responsibilities include:
Proposing team members together with the (Associate) Therapeutic Area Head.
Representing ECD/MST on:
・Core Team
・Therapeutic Area Leadership Committee (TALC)
・Clinical Expert Committee (CEC)
・Human Pharma Steering Committee (HPSC)

Additional activities:
・Oversees interactions with:
　　External experts
　　Advisory boards
　　Adjudication committees
　　Safety Data Monitoring Boards
・Reviews and approves publications related to the project in collaboration with the Medical Head.

・Identifies studies that should be conducted.

・Provides input into Medical Affairs strategic documents, including:

Scientific Platform
Publication Plan
Product Maintenance and Optimization Summary

■Key Accountabilities of the Clinical Program Leader in Experimental Medicine Japan
■External Expert Engagement
・Map and prioritize External Experts (EEs) in the region, including:

　　Indication experts
　　Translational clinicians
　　Phase II trialists
・Build and maintain relationships to obtain scientific input and support trial success.
・Facilitate scientific discussions to ensure regional expertise contributes to:
　　Emerging science and innovation relevant to TA Inflammation
　　Proof-of-Concept (PoC) study design, including endpoint selection
　　Biomarker strategy

■Regulatory and Organizational Requirements
Operates within the requirements of global Standard Operating Procedures (SOPs) and working instructions.

■Job Complexity
Complex due to:
・Global nature of the role
・Matrix organization
・Direct multidisciplinary interaction

■Interfaces
Works with:
・Global matrix teams
・Regional BI counterparts
・External partners
　　Academic institutions
　　Investigators

■Also interfaces with:
・Regulatory authorities
・International societies
・Other relevant international stakeholders

求める経験 / スキル

■Job Expertise
Preferred:
PhD or MD
Specialist in a specific Therapeutic Area or equivalent expertise

■Job Impact
Responsible for the project's medical budget.

■Minimum Education / Degree Requirements
Preferred:

PhD or MD
Board certification in a specific Therapeutic Area or equivalent clinical experience

■Required Capabilities (Skills, Experience, Competencies)
PhD or MD preferred (specialist in a Therapeutic Area or equivalent) with strong clinical expertise.
Up to 3 years of pharmaceutical industry experience preferred.
Successful track record in planning, conducting, and publishing basic science and/or clinical research.
Strong medical and scientific leadership ability to drive high-priority projects across global matrix teams, regional BI counterparts, and external partners.
Ability to act with composure and resilience under pressure.
Strong project management skills.
Experience interacting with regulatory authorities, international societies, and other key stakeholders.
Strong communication and presentation skills.
Excellent cross-functional collaboration skills and ability to work effectively in virtual teams.
Ability to establish strong partnerships with top external experts, national/international societies, and other stakeholders.
Ability to engage in advanced scientific knowledge exchange.
Fluency in both Japanese and English.

従業員数

1,750名（2026年1月現在）

勤務地

東京都

想定年収

1,000 万円 ~ 1,800 万円

従業員数

1,750名（2026年1月現在）

Clinical Development Senior Manager

ルンドベック・ジャパン株式会社

課長以上
外資系企業

仕事内容

Purpose of the job:
Lead and drive the overall clinical development process in Japan, including development strategy planning and clinical trial execution, in close collaboration with Japan Drug Development, Global Clinical Focus Teams, and other key stakeholders at headquarters and locally. The role is expected to foster strong cross-functional collaboration, shared accountability, and operational excellence to accelerate patient access to innovative treatments.

Responsibilities:
• Develop and execute robust clinical development strategies aligned with global objectives and local regulatory requirements.
• Deliver high-quality clinical trial data through innovative, efficient, and standardized operational processes.
• Lead Japan clinical development activities in partnership with local and global cross-functional teams, while providing strong scientific and strategic input.
• Build productive relationships with PMDA to achieve alignment on Clinical Development Plans (CDP), clinical trial designs, submission strategies, and approval pathways in collaboration with Regulatory Affairs.Oversee and manage CROs to ensure timely trial execution and high-quality deliverables.

Tasks:
• Develop and optimize Japan-specific clinical development strategies in alignment with global development plans through close collaboration with headquarters.
• Contribute to alignment of Japanese CDPs with PMDA and local Key External Experts (KOLs).
• Serve as the local clinical representative in PMDA consultations.
• Support preparation and review of J-NDA CTD documentation.
• Contribute to the successful execution of clinical trials, including feasibility, site selection, patient recruitment, and site engagement, through effective CRO oversight.
• Establish and maintain strong relationships with investigators, academic experts, and other external stakeholders.
• Foster a collaborative and positive working environment and maintain strong partnerships across Lundbeck

求める経験 / スキル

Education / Certifications:
• Bachelor’s degree (scientific background) required, and advanced degree preferred
• Medical Doctor with experience in Neurology or Pharmacist is preferable

Experiences
• Minimum 10 years of experience in clinical development within the pharmaceutical industry and/or CRO environment. (Experience within a pharmaceutical company is preferred.)
• Demonstrated experience in developing Clinical Development Plans (CDPs).
• Experience in neurological disease development, including neurodegenerative diseases, neuroimmunology, or migraine.
• Hands-on experience interacting with PMDA/MHLW.
• Experience managing global and/or Asian clinical trials.
• Proven ability to work effectively within global cross-functional teams.
• Preferably, prior people management experience, team leadership responsibilities, or a strong aspiration to further develop leadership capabilities toward future management roles.
Competencies:
• English skill (verbal and written)
• Demonstrates Lundbeck values of Curiosity, Adaptability, and Accountability.
• Excellent communication and presentation skills in both Japanese and English.
• Foster strong cross-functional collaboration and shared accountability across local and global teams to successfully deliver clinical development objectives and accelerate patient access to innovative treatments.
• Demonstrate flexibility in navigating evolving clinical landscapes, operational challenges, and changing business priorities while adapting development strategies to local and global needs.
• Maintain a results-oriented mindset by ensuring high-quality and timely execution of clinical development activities, while balancing scientific rigor & latest scientific evolvements in the field, patient safety and operational excellence
• Uphold the highest ethical standards, transparency, and compliance in all clinical development activities and interactions. Foster a psychologically safe environment that encourages open communication, diverse perspectives, and continuous learning.
• Solid understanding of GCP/ICH guidelines and applicable clinical trial regulations.

従業員数

100名

勤務地

東京都

想定年収

800 万円 ~ 1,400 万円

従業員数

100名

Sr. Manager, Patient Safety

ルンドベック・ジャパン株式会社

課長以上
外資系企業

仕事内容

Purpose of the job:
This role is a critical addition to Lundbeck Japan's Drug Development organization, reporting to the Head of Patient Safety Japan. The individual will serve as a senior pharmacovigilance professional responsible for supporting the safety oversight of Lundbeck's expanding product portfolio in Japan, including both marketed products and pipeline assets approaching regulatory milestones. The role is positioned at a level where the successful candidate would be expected to develop toward readiness for broader safety-responsible leadership, including eligibility for the Deputy Anseki designation under the PMD Act and J-GVP regulations. This requires someone who combines deep pharmacovigilance expertise with the independence, judgment, and collaborative approach needed to contribute meaningfully in a lean and growing organization.

Responsibilities:
• Serve as the primary backup to the Head of Patient Safety Japan, including acting as Deputy Anseki when required.
• Exercise independent and accountable judgment on safety-related matters in accordance with Japan regulatory requirements, global pharmacovigilance standards, Anseki’s direction. and company strategy.
• Provide safety oversight across Lundbeck Japan's portfolio, including marketed products and clinical-stage assets, ensuring compliance with J-GVP and applicable global pharmacovigilance regulations.
• Manage and oversee relationships with external vendors responsible for case processing, safety database operations, and related outsourced pharmacovigilance activities, ensuring contractual compliance, data quality, and timely regulatory reporting.
• Maintain, and oversee safety operational process governance, including the maintenance of local QMS documents and Pharmacovigilance agreement(PVA) or Safety Data Exchange Agreements (SDEAs) with third parties .
• Contribute to the establishment and maintenance of Japan Risk Management Plans (J-RMPs), including risk minimization strategies and Early Post-marketing Phase Vigilance (EPPV) activities for new product launches collaborating with global and local stakeholders.
• Interface with the PMDA on safety-related matters, including support for regulatory inspections, GVP self-inspections, and responses to regulatory inquiries.
• Collaborate with global Patient Safety counterparts to ensure alignment on signal detection, benefit-risk assessment, aggregate reporting, and safety data exchange.
• Partner cross-functionally with Clinical Development, Regulatory Affairs, Product Quality, and Medical Affairs to ensure integrated safety input across development and commercial activities.
• Provide scientific and strategic input on safety-related components of regulatory submissions, in collaboration with global Patient Safety, including contributions to J-NDA safety sections, J-DSURs, J-PSURs, and re-examination dossiers.
• Identify and drive continuous improvement in pharmacovigilance systems within the Japan Patient Safety function.

Tasks:
• Provide managerial oversight of pharmacovigilance operations as Deputy Anseki when required, including supervision of team activities and end-to-end oversight of safety processes, to ensure regulatory compliance, quality, and operational effectiveness.
• Conduct review and quality oversight of Individual Case Safety Reports (ICSRs) from both post-marketing and clinical trial sources in accordance with Japan regulatory requirements, ensuring accuracy, completeness, and appropriate judgement.
• Prepare, review, and ensure timely submission of periodic safety reports (J-PSURs, J-DSURs) and annual infection reports as required.
• Develop and maintain inspection-readiness documentation and support the execution of internal self-inspections and external regulatory audits.
• Establish and manage post-marketing safety activities (including postmarketing surveillance, clinical research, market research, and patient support programs) in compliance with pharmacovigilance requirements, in collaboration with relevant internal functions and vendor staff.
• Support launch readiness activities for new products by contributing to safety planning, and EPPV design.
• Monitor regulatory developments and evolving PMDA expectations related to pharmacovigilance and drive operational or procedural adjustments.

求める経験 / スキル

Education / Certifications:
• Bachelor's degree in pharmacy, life sciences, nursing, public health, or related field required. Advanced degree (MSc, PhD, PharmD) preferred.
• Good Clinical Practice (GCP) and Good Vigilance Practice (GVP) training.

Experiences
• Minimum 10 years of pharmacovigilance experience in the pharmaceutical or biotechnology industry, with substantial exposure to Japan-specific PV regulations (GCP,GVP).
• Demonstrated experience interacting with the PMDA and supporting regulatory inspections.
• Proven track record in managing outsourced pharmacovigilance operations, including CRO/vendor oversight, case processing quality management, and PVA governance.
• Experience contributing to or leading the preparation of J-RMPs, aggregate report including J-DSURs, J-PSURs, re-examination dossiers, and safety sections of regulatory submissions.
• Strong understanding of global pharmacovigilance frameworks (ICH, EU GVP) and how they interface with Japanese requirements.
• Prior experience in a Deputy Anseki or equivalent safety-responsible backup role is strongly preferred.
• Experience supporting safety operations during product launches, including EPPV and post-marketing surveillance (PMS), is a distinct advantage.

Competencies:
• Regulatory and Scientific Expertise: Deep working knowledge of GVP, GCP, and global pharmacovigilance regulations, combined with the ability to interpret and apply complex regulatory requirements in practical operational contexts.
• Oversight and Process Thinking: Strong orientation toward process governance, vendor management discipline, and continuous improvement in how pharmacovigilance operations are structured and executed.
• Curiosity and Strategic Maturity: Demonstrates an open-minded approach to emerging and evolving situations and actively explores how Patient Safety can contribute. Ability to think beyond day-to-day operations and contribute to the broader strategic direction of the Patient Safety function, with the judgment and confidence to serve as a credible sparring partner to the function head.
• Flexible mindset: Demonstrates a flexible mindset, with the ability to generate multiple approaches to demonstrating compliance with both Japan and global requirements, and to make optimal, situation-appropriate judgments.
• Independence and Accountability: Capable of operating with limited supervision, taking ownership of deliverables, and making sound decisions under time pressure
in a organizational environment.
• Cross-functional Collaboration: Effective at working across functional boundaries with Clinical Development, Regulatory Affairs, Product Quality, and Medical Affairs, and across organizational boundaries with global Patient Safety counterparts.
• Communication: Strong written and verbal communication skills in both Japanese and English, with the ability to present complex safety information clearly to internal stakeholders and regulatory authorities.

従業員数

100名

勤務地

東京都

想定年収

800 万円 ~ 1,400 万円

従業員数

100名

製造リーダー（注射剤・固形剤）

シミックCMO株式会社

仕事内容

「より良い薬をより早く患者さまのもとへ」
シミックCMO株式会社では医薬品の受託製造を行っております。
医薬品の安定供給を行う工場を最前線で支え、工場と一緒に成長してみませんか。

【足利工場魅力】
・既存の注射剤に加え、2018年に新注射製剤棟を設立し、注射剤製造を行うマザー工場となっています。
・固形製剤、注射剤全般の製造を担っており、ほぼ全ての剤形に関わることが可能です。
・新棟は国内CDMOの中でも設備は最高級レベルを誇ります。
・複数社から受託⇒各社の情報集積⇒高い技術を集約・技術力UP⇒信頼獲得⇒業績UPの好循環が生まれています。
・従業員の駐車スペースも十分に確保していますので、お車での通勤も快適です。

【求人魅力】
・リーダーシップ研修やビジネススキルに関する教育も充実しており、マネジメント職へのキャリアアップにも挑戦いただけます。

【業務詳細】
注射剤・固形剤の製剤製造に関する業務をご担当頂きます。
社内外関係者と協力し、GMP業務の経験を生かして、製造オペレーションの業務・メンバーをリードしていただきます。

＜オペレーション業務例＞
・注射剤原材料の秤量・調製作業
・使用資材の洗浄・滅菌作業
・注射剤の充てん作業
・各種製造設備のオペレーター業務（打錠機・コーティング機等）
・製造支援設備（製薬用水・空調）の日常点検等

求める経験 / スキル

【必須要件】
・医薬品製造業務経験

【歓迎要件】
・注射剤製造業務経験

従業員数

1,387名（（2026年4月現在））

勤務地

栃木県

想定年収

500 万円 ~ 非公開

従業員数

1,387名（（2026年4月現在））

Clinical Site Partner, Clinical Operations

ギリアド・サイエンシズ株式会社

課長以上
外資系企業

仕事内容

At Gilead, we’re creating a healthier world for all people. For more than 35 years, we’ve tackled diseases such as HIV, viral hepatitis, COVID-19 and cancer – working relentlessly to develop therapies that help improve lives and to ensure access to these therapies across the globe. We continue to fight against the world’s biggest health challenges, and our mission requires collaboration, determination and a relentless drive to make a difference.

Every member of Gilead’s team plays a critical role in the discovery and development of life-changing scientific innovations. Our employees are our greatest asset as we work to achieve our bold ambitions, and we’re looking for the next wave of passionate and ambitious people ready to make a direct impact.

We believe every employee deserves a great leader. People Leaders are the cornerstone to the employee experience at Gilead and Kite. As a people leader now or in the future, you are the key driver in evolving our culture and creating an environment where every employee feels included, developed and empowered to fulfil their aspirations. Join Gilead and help create possible, together.

Job Description

The role covers site identification and qualification, enrollment planning and execution, timely database lock, and study closeout.
The position serves as a communication bridge and escalation point between investigator sites and the Development organization, working with internal teams and site staff to resolve issues and remove barriers.
The position also manages relationships with regional and local patient advocacy groups and communities to ensure that the patient perspective is incorporated throughout product development.
• Establish and maintain strong professional and collaborative relationships with investigator sites, leveraging disease area expertise to optimize clinical trial delivery.
• Develop strategies to provide high-touch support for preferred sites and strengthen the company’s position as a sponsor of choice.
• Track key performance metrics to assess site performance and identify opportunities for and continuous improvement.
• Maintain therapeutic and technical expertise to enable scientific discussions with investigators and site personnel.
• Share development pipeline information with investigators/site personnel and collect field-based intelligence on the competitive landscape, patient pathways, and operational considerations.
• Support study teams and CROs to deliver trials from initiation through closeout, including feasibility, site recommendations, initiation visits, communication facilitation, and enrollment support.
• Support the development and implementation of site risk plans to achieve key study and site milestones such as first patient first visit, enrollment commitments, and database lock.
• Serve as a local escalation point for investigator sites, partnering with appropriate stakeholders to resolve issues and remove barriers at site and/or country level.
• Proactively communicate and escalate site issues, and partner with internal functional areas to develop mitigation strategies and implement solutions.
• Leverage and present metrics to inform site, country, and regional decision-making.
• Develop local knowledge of site capabilities and past performance and provide input into recruitment forecasts and methodologies while monitoring performance and taking action to maintain timelines.
• Partner closely with Clinical Operations, Clinical Development, and Medical Affairs to ensure effective communication and unified messaging to investigator sites.
• Therapeutic Area: Oncology, Virology and Inflammation disease

求める経験 / スキル

Required Qualifications:
• 10+ years of Clinical Operations experience in a pharmaceutical company, biotech, or CRO
• Hands-on experience managing clinical trials from start-up through closeout
• Strong investigator site relationship management and engagement experience
• Experience with site feasibility, site selection, site activation, and enrollment support
• Proven ability to resolve site issues and manage escalations
• Strong understanding of ICH-GCP and local clinical trial regulations
• Experience using KPIs and performance metrics to drive trial execution
• Therapeutic area expertise in Oncology, Virology, or Inflammation/Immunology
• Ability to collaborate effectively with Clinical Operations, Clinical Development, Medical Affairs, and CRO partners
• Strong communication and stakeholder management skills
• Business-level English proficiency and native-level Japanese proficiency

Preferred Qualifications:
• Experience as a Clinical Site Partner, Site Engagement Lead, Site Partnership Manager, or similar role
• Oncology clinical trial experience, particularly in complex or global studies
• Experience with patient recruitment acceleration and enrollment recovery initiatives
• Experience developing site risk mitigation and performance improvement strategies
• Global clinical trial experience within a matrix organization
• Experience leveraging site and country-level metrics to support strategic decision-making
• Established relationships with key investigator sites and KOLs
• Experience collaborating closely with Medical Affairs and MSL teams
• Advanced degree in Life Sciences, Pharmacy, Nursing, or a related field

従業員数

752名（2026年3月現在）

勤務地

東京都

想定年収

1,200 万円 ~ 1,500 万円

従業員数

752名（2026年3月現在）

[Innovative Medicine] R&D, Sr. Scientist Biostatistics, Statistics & Decision Sciences Japan, Global Development (R-079886)

ヤンセンファーマ株式会社

外資系企業

仕事内容

Job Description

Position Summary：

The Senior Scientist supports the design and execution of studies and experiments for Clinical Development and Medical Affairs programs at J&J Innovative Medicines (J&J IM), with evolving supervision. Support is provided to statistical analysis, interpretation, and reporting or communication of data evidence towards programs for research, development, and/or marketed product needs in J&J IM.

The position collaborates with Quantitative Sciences & Clinical Pharmacology (QSCP) functions and other drug development scientists. This role supports statistical aspects of key business and regulatory commitments, assists program plans, and represents Statistics & Decision Sciences (SDS) in various teams or working groups.

The Senior Scientist practices J&J leadership principles and values aligned with the company’s Credo and purpose.

Principal Responsibilities

-Expertise-

・Exhibits effective proficiency in data analytics, grounded in statistical principles that lead to successful study support. Demonstrates competence in utilizing pertinent computational tools for research objectives related to studies, experiments, or trials, including full proficiency in R and SAS along with familiarity with other relevant computational tools, including innovative data-adaptive methods and artificial intelligence.

・Applies high quality statistical methodology in assigned projects, showcasing an understanding of the disease/scientific/functional area and compliance with health authority standards. Acts with accountability, agility, and transparency. Exhibits knowledge of pharmaceutical research and development strategies and execution.

・Acquires and demonstrates knowledge for at least one disease area/target. Provides input in optimizing study designs to meet objectives, and supports scenario simulations and sample size calculations informed by technical and disease/scientific/functional area specific knowledge.

・Able to address complexities related to scientific, statistical, regulatory, operational, and partnership aspects. Progresses to more complex programs upon mastering standard ones.

-Innovation-

・Implements advanced statistical techniques to address complex project or program features. Embraces opportunities of assessing and executing successful alternative or innovative approaches to statistical methodologies or business processes.

・Proactively provides input to team to help optimize study or trial designs in line with study or indication level objectives to enhance inferential insights while minimizing time, cost, and study risk.

・Strongly assists in problem-solving and troubleshooting at a program level, including regulatory and decision-making support. Collaborates cross-functionally to identify and resolve issues.

・Engages in process improvement and standards development initiatives.

-Impact-

・Builds cross-functional partnerships with internal colleagues and external partners (e.g., Contract Research Organizations (CROs), consultants) to achieve results for project-specific needs, focusing on enhancing communication, efficiency, and productivity.

・Collaborates effectively with SDS colleagues and external partners to meet program needs. Represents Statistics & Decision Sciences on various teams, working groups. Works within SDS and QSCP for unified and integrated quantitative input in drug development.

・Represents Statistics & Decision Sciences in cross-functional and intra-departmental teams or working groups pertaining to scientific or process initiatives. Delivers high-quality and timely deliverables as evaluated by stakeholders such as the project team, clinical trial team, and the Statistics Area Head. Holds responsibility and accountability for individual project execution, managing meetings with relevant project team members, reporting activities, exploratory analyses/graphics, and additional analyses to support publications for individual clinical trials/studies/projects.

・Identifies vital external scientific and statistical trends, driving the advancement of statistical methodologies through scholarly publications. Engages actively in presentations at key forums and publishes work addressing business-related needs. Contributes as a member of professional organizations.

-Key Behaviors-

・Displays a proactive approach and cultivates a growth mindset for personal development. Keeps up-to-date with the changing landscapes in drug development and statistical methodology, and shows adaptability to optimize contributions to the J&J IM pipeline. Continuously grows global and big picture perspectives.

・Exhibits strong written, oral, and interpersonal communication skills, and demonstrates proficiency in collaborating with non-statisticians by translating intricate statistical concepts for drug research and development partners. Effectively communicates statistical findings to program stakeholders and broader non-technical audiences utilizing interactive graphical tools.

・Supervises contractors/special assignment personnel/interns/co-ops as required.

・Takes responsibility and accountability for the quality and timeliness of project deliverables as assessed by stakeholders from respective projects or programs. Follows best practices for Good Clinical, or other pertinent GxP activities and requirements, including Data Integrity. Complies with organization and company standard operating procedures in a timely fashion, such as required training and project time accounting. Demonstrates understanding and alignment with pertinent regulatory guidance. Ensures that documents, programs, and all other deliverables are consistent and adhere to project and company standards.

-Area Specific Responsibilities and Accountabilities-

The content in this section supplements the Principal Responsibilities section above. For an individual, the applicable content corresponds to their assigned area within Statistics & Decision Sciences.

-Japan Post Marketing Surveillance-

Post Marketing Surveillance (PMS) business needs in Japan are supported at this level, as the Pharmaceutical and Medical Devices Agency (PDMA) Japan health authority may require a marketed product in Japan to conduct a post marketing surveillance study.

求める経験 / スキル

-Education and Experience-

・Ph.D. in Statistics or related field with relevant experience, or Master’s in Statistics or related field with commensurate years of relevant experience.

・Proficient in SAS and R programming, and other relevant computing tools (e.g., East Horizon, RPACT, FACTS, Python).

・Excellent interpersonal, verbal, and written communication skills in both of Japanese and English languages.

・Demonstrated ability to work in interdisciplinary contexts outside statistics.

-Other-

Travel (domestic or international) anticipated to be <10%.

-Required Skills-

-Preferred Skills-
Advanced Analytics, Biostatistics, Clinical Trials, Collaboration, Consulting, Critical Thinking, Data Privacy Standards, Data Quality, Data Savvy, Digital Fluency, Good Clinical Practice (GCP), Quality Assurance (QA), Report Writing, Standard Operating Procedure (SOP), Statistical Analysis Systems (SAS) Programming, Statistics, Systems Development, Technologically Savvy

従業員数

2,000名（2025年7月1日現在）

勤務地

東京都

想定年収

700 万円 ~ 1,400 万円

従業員数

2,000名（2025年7月1日現在）

Clinical Trial Physician

ブリストル・マイヤーズスクイブ株式会社

課長以上
外資系企業

仕事内容

Position Summary

The Japan Clinical Trial Physician sits within Clinical Development, which is dedicated to the effective design and execution of drug development. Clinical Trial Physician contributes and drives clinical development strategy, design, execution, and interpretation of clinical trials closely working with Japan Clinical Leads and global clinical counterpart.

Duties/Responsibilities

Medical Monitoring

Conducts medical data review of trial data, including eligibility review
Holds responsibility for site interactions in partnership with the Japan Clinical Lead or Clinical Scientist for medical questions and education (including safety management guidelines)
Holds responsibility for assessment of key safety-related serious adverse events of R&D clinical trials in partnership with Worldwide Patient Safety and oversees safety narratives
Collaborate with Japan Clinical Lead or Clinical Scientist and inputs into protocols, providing medical strategic oversight in protocol development (input on inclusion/exclusion and other safety-related clinical considerations)
Fulfills GCP and compliance obligations for clinical conduct and maintains all required training
The range of CTP’s medical accountability/responsibility differs in global vs local studies. For global studies, Japan CTP is assumed to assist global CTP as needed from local perspectives, e.g. provide local medical related input, resolve local medical related issues.
Japan CTP could be expected to take a primary CTP role for local initiated trials or program
Clinical Development Expertise & Strategy

In collaboration with the Japan Program Development Team such as Clinical Lead, designs and develops project/clinical plans and protocols with a strong strategic focus based on knowledge of asset/drug, disease area and relevant science in order to meet regulatory and disease strategy targets
Provides oversight and medical accountability for a group of studies
Leads the analysis of benefit/risk for clinical development protocols and projects in a matrix team environment working with Japan TA
Partners with Japan the Japan Program Development Team such as Clinical Lead to support executional delivery of studies (e.g., enrollment review, as well as adjudication for protocol violations, significant, non-significant deviations etc.)
Identifies and builds relationships with principal investigators. Identifies and cultivates thought leaders in order to gain their inputs on emerging science in drug and biomarker research, disease knowledge, and design of clinical development studies and programs
Maintains a strong medical/scientific reputation within the disease area. Has in-depth knowledge of etiology, natural history, diagnosis, and treatment of the disorder. Holds strong expertise in the disease area by attending scientific conferences and ongoing review of the literature
Keeps abreast of development and regulatory issues related to other competitive or relevant compounds in development and how our portfolio fits into the competitive landscape
Provides ongoing medical education in partnership with collaborating Clinical Scientists to allow for protocol-specific training, supporting the study team, investigators, and others
Health Authority Interactions & Publications

Contributes to and serves as medical point of expertise in key Health Authority interactions and advisory board meetings as Clinical Trial Physician
Authors/drafts clinical content for CSRs, regulatory reports, briefing books and submission documents to support closure, clinical narratives, reporting and filling of the study in partnership with TA such as Clinical Lead or Clinical Scientist

求める経験 / スキル

Key Competency Requirements:

Ability to deliver the outcomes under the ambiguity or complexity
Ability to partner with people at all levels of the organization
Ability for proactive proposal building and proactive action takings without detailed instructions
Ability to respond flexibly to the changing project/task priorities and work assignments.
Ability to influence and negotiate without specific authority.
Ability to take a risk and to manage it without jeopardizing quality and/or compliance
Ability to build action plans based on the organization vision
Acts to makes a balance between short-term performance and long-term vision.
Fluent in spoken and written English & Japanese for business is preferred

従業員数

1,429名（※2025年6月時点）

勤務地

東京都

想定年収

800 万円 ~ 1,800 万円

従業員数

1,429名（※2025年6月時点）

Senior Manager, Portfolio and Program Manager

ブリストル・マイヤーズスクイブ株式会社

課長以上
外資系企業

仕事内容

Position Summary

Portfolio and Project Manager is responsible for driving end-to-end project execution, ensuring alignment with therapeutic area, disease area and compound strategies. This TA PPM role is a key partner to the Strategy and Portfolio Management team, collaborating to drive integrated development plans in collaboration with global and Japan program teams, manages project scopes such as timelines across multiple compounds, and monitors project status to proactively address risks and delays. Key responsibilities include proactive risk management and issue recovery actions, KPI tracking, coordinating resource allocation, and supporting governance processes. Additionally, the Project and Portfolio Manager supports TA’s or Program’s decision-making (integrating valuation metrics such as eDC and PTRS) to achieve project and corporate objectives and also supports continuous improvement through robust partnership with the JPT and functions such as TA department and through transparent reporting.

Duties/Responsibilities

■Strategic Partnership:
Serve as a CD TA partner to the Strategy and Portfolio Management team, ensuring alignment of project objectives with portfolio strategy, prioritization, and resource management.
Collaborate on portfolio reviews, risk vs. value analysis, and continuous improvement initiatives.

■Risk Management:
Build integrated risk management plans for all projects, with special attention to disease areas.
Apply standardized risk management frameworks, including risk identification, assessment, mitigation, escalation, and reporting, in partnership with the Strategy and Portfolio Management team.
Facilitate risk management training and adoption of new tools and processes across teams such as Japan Program teams or TA representatives.

■Milestone, KPI & Metrics Management:
Define, track, and report on Milestones and key performance indicators (KPIs) for project delivery, risk mitigation, and portfolio health, in collaboration with the Strategy and Portfolio Management team.
Use data-driven insights to inform decision-making and continuous improvement.

■Project Planning & Execution:
To keep program scopes, overseeing integrated development plans, timelines, and milestones, ensuring alignment with TA, disease area, and compound strategies.
Build an appropriate project initiation approach from both strategy and operational viewpoint
Monitor project status, proactively address risks and delays, and coordinate resource allocation.

■Valuation & Portfolio Management:
Develop and apply valuation metrics (factors for eNPV such as eDC, PTRS, etc.) to support portfolio optimization and prioritization.
Partner with the Strategy and Portfolio Management team to drive portfolio excellence and value delivery.

求める経験 / スキル

A bachelor’s degree in life science (advanced degree Ph.D. in scientific discipline and/or MBA is preferred)
At least 3 years experience in project management and/or functional management in one or more of the Pharmaceutical R&D functions
Professional project management certification and/or diploma (PMP) highly preferred
Demonstrated experience in risk management, KPI tracking, and portfolio strategy.
Experience of managing or leading global or multi-country projects
Ability to deliver the outcomes under the ambiguity or complexity
Strong partnership skills with ability to collaborate across functions with people at all levels of the organization
Ability for proactive proposal building and proactive action takings without detailed instructions
Ability to respond flexibly to the changing project/task priorities and work assignments.
Ability to influence and negotiate without specific authority.
Ability to take a risk and to manage it without jeopardizing quality and/or compliance
Ability to build a forecast and action plan based on the organization strategy
Acts to make a balance between short-term performance and long-term strategy.
Strong analytical skills with high IT literacy including proficiency in project management and analytical tools
Experience to ensure the business complies with all legal legislation through compliance with the highest standards of pharmaceutical industry propriety
Experience to assure business compliance and control within the Health Care Compliance obligations, Sarbanes Oxley and other audit requirements
Strong English communication skills

従業員数

1,429名（※2025年6月時点）

勤務地

東京都

想定年収

1,000 万円 ~ 1,500 万円

従業員数

1,429名（※2025年6月時点）

Senior Manager, Senior Japan Clinical Lead

ブリストル・マイヤーズスクイブ株式会社

課長以上
外資系企業

仕事内容

◆Position Summary / Objective
The Japan Clinical Lead (JCL) serves as the clinical point of accountability for the Japan Development Team and is responsible for the overall Japan clinical development plan for asset(s) in one or more indication(s). JCL ensures studies are aligned with target la bel indications and designed to meet regulatory, quality, medical, and access goals to fit Japan specific requirement/situation. JCL is responsible for implementation, planning, and execution of assigned clinical trial activities, and leads communication with the external stakeholders (e.g. TLs, PI) to efficiently promote responsible clinical program. Accountable for the scientific data evaluation, interpretation and documentation for assigned project development program. For Japan local study, fulfills the CS role defined in Global SOP.

◆Position Responsibilities
Accountable for the clinical contribution to the development of each indication strategy, including registrational and non-registrational studies, with the support of the CTPs within the asset and/or indication
Accountable for the design, execution, and analyses of each study
Accountable for clinical content for CSRs and regulatory documents (e.g., briefing books submission documents and regulatory responses)
Champions a quality-focused mindset and ensures adherence to GCP and compliance obligations for clinical conduct
Represents Clinical Development in both internal and external forums as the consulted authority for the disease area, including within Business Development function
Provides clinical leadership and disease area expertise into integrated disease area strategies
Collaborate and serve as primary liaison between external partners for scientific advice
Serves as Primary Clinical Representative in Regulatory interactions
Sets executional priorities and partners with CTP and operation team to support executional delivery of studies
Accountable for top line data with support of CTP and Statisticians
Maintain a thorough understanding of assigned protocols and protocol requirements; educate supporting team members
Evaluate innovative trial designs (collaboration with Japan CTP) • Ensure global clinical study protocol is applicable to local medical practice (manage local protocol amendment, if needed)
Proactively identifies potential study level risks and drives the execution of mitigation strategies
Serve as CS in Japan local studies

o Responsible for implementation, planning, and execution of assigned clinical trial activities
o Successfully leads, plans, and executes trial level activities for multiple trials with minimal to moderate level of supervision
o Co-Leads study team meetings in partnership with Global Trial Manager; and collaborate with cross functional study team members
o Plan and lead the implementation all study startup/conduct/close-out activities as applicable (collaboration with GTM)
o Protocol and ICF development process; including writing, reviewing, adjudication/resolution of cross functional comments and ensuring high clinical quality (collaboration with Scientific Writing)
o Site-facing activities such as training and serving as primary contact for clinical questions
o Activities related to data generation and validation, including CRF design, clinical data review/query resolution; ensure consistent, quality data review (collaboration with DM)
o Clinical data trend identification; provide trends and escalate questions to Japan CTP
o Develop clinical narrative plan; review clinical narratives
o Provision of information required by Global Trial Manager for development of trial budget, CRO scope of work, etc.
o Review development of site and CRA training materials and presentation at SIV and Investigator meetings and support on Study committee (e.g., DMC) activities

Demonstrate leadership as an active member of cross functional teams, task forces, or local and global initiatives
Effectively influence team and collaborate with senior stakeholders, address complex problems and challenges with positive outlook, able to deliver results with high level professionalism
Coach the CL in the Clinical Lead work for development of products in Japan from study planning to JNDA filing and thereafter

求める経験 / スキル

◆Degree Requirements
A minimum of 5 years of clinical development / industry experience preferred
Expertise in the design, analysis, publication and execution of multiple clinical trials (e.g. significant experience as a senior clinical leader).
Adequate knowledge of pharmaceutical development process.
Strong experience in clinical science, clinical research, or equivalent.
Experience in a matrix team composed of multiple functional organizations.

◆Experience Requirements
Ability to deliver the outcomes under the ambiguity or complexity
Ability to partner with people at all levels of the organization
Ability for proactive proposal building and proactive action takings without detailed instructions
Ability to respond flexibly to the changing project/task priorities and work assignments.
Ability to influence and negotiate without specific authority.
Ability to take a risk and to manage it without jeopardizing quality and/or compliance
Proficient knowledge and skills to support program specific data review, trend identification, data interpretation
Proficient knowledge of GCP/ICH, drug development process, study design, statistics, clinical operations
Able to synthesize internal and external data to produce a clinical strategy
Able to ensure that the clinical program will result in a viable registrational strategy
Able to work with other stakeholders to ensure a robust enterprise level strategy for asset(s) and indication(s) including early, late and post-marketing development in Japan
Fluent in spoken and written English for business is preferred

従業員数

1,429名（※2025年6月時点）

勤務地

東京都

想定年収

800 万円 ~ 1,400 万円

従業員数

1,429名（※2025年6月時点）

Clinical Development Medical, Associate Director, Research and Development - Vaccines

ファイザーR&D合同会社

課長以上
外資系企業

仕事内容

■Role Summary
The clinician contributes towards providing medical and scientific expertise and oversight for Clinical Trials conducted worldwide with a primary focus in Japan and the Asia-Pacific region.
The clinician may be required to design a development strategy for multiple protocols designed to obtain approval particularly in Japan and other countries in Asia for a compound or group of compounds

■Role Responsibilities
Protocol design and strategy:

Contributes towards the medical input during protocol development and updates to the clinical development plan.
Work closely with other clinicians and Japan study team members to ensure that documents (protocol, Informed Consent Document [ICD], etc.) meet regulatory requirements and company policy and has been reviewed by IRB/IECs.
Provides medical input into country feasibility.

Accountable for safety across the study:

Provide study team with medical advice for all medical issues during risk assessment and mitigation planning to enable quality, compliance and patient safety at the trial, site and patient level.
Ensures development of and adherence to the Safety Surveillance Review Plan (SSRP). Consistent with the SSRP, performs and documents regular review of individual subject safety data, and performs review of cumulative safety data with the safety risk lead. As appropriate, the clinician may delegate these responsibilities to the study clinician scientist/Japan Clinical Lead identified in the SSRP. The specific components of safety data review are detailed in the appropriate SOPs and the “Safety Data Review Guide – for Clinicians.”
Monitor study safety issues and provide input to serious adverse events (SAEs) reports. Provides appropriate medical context in terms of risk factors, medical history and other important medical factors required to put the SAE or AE into appropriate medical context.
Participates in the Safety Review Team to evaluate medical benefits/risks to support targeted clinical indications.
Reviews literature as needed to respond to safety questions or those posed by the Safety Review Team, Data Monitoring Committee (DMC) or other individuals or bodies involved with the study.
Communicates safety information to sites across the study and provides responses to questions on safety.

Support study team:

With supervision of Global Development lead provides clinical input to protocol/study team for monitoring guidelines, statistics analysis plans, ICDs, clinical review forms, data edit checks, data quality planning, as needed
Contributes to contract research organization / vendor selection to ensure study is conducted consistent with protocol requirements, clinical plan expectations, and study timelines; this includes ensuring medical/technical requirements for data integrity are applied.
Works with study team to ensure high quality of data e.g., appropriate patient population, adequacy of clinical assessments as study is ongoing.
Contributes to medical review and interpretation of efficacy and safety data from clinical trials; this includes delivery of top-line report in collaboration with study statistician, and delivery of clinical study report in collaboration with medical writer and accountable for overall quality and timeliness of analysis and reporting.
Provides protocol specific training to study team, investigators, clinical research associate, and others.
Interacts with healthcare professionals at sites during the conduct of the study to enable quality, compliance and patient safety at the trial, site and patient level.
Interacts with DMCs and steering committees as required.
Notifies appropriate study team personnel of the need to inform investigators of any changes in research activity and any significant new adverse events.
Monitor investigator compliance with protocol and regulatory requirements.
Support study team in issues resolution, study closeout, audit responses, inspection readiness, etc.
Supports the program team:
Works closely with Japan development teams providing medical input and knowledge throughout the program from inception through completion and regulatory approval.
Under supervision (director/Sr director) authors clinical sections of regulatory documents (Investigator Brochure, Annual Reports, Investigational New Drug sections, clinical study report, clinical overview for JNDA submissions).
May co-author abstracts, posters, presentations and publications.
May contribute budget execution of protocols.
Interact with regulatory authorities, key opinion leaders, and principal investigators:

May support Clinical Regulatory Authority interactions, particularly with the PMDA, accountable for providing responses.
Liaise with Key Opinion Leaders and Principal Investigators in countries to build a Key Opinion Leaders /Principal Investigators network for new trials.

求める経験 / スキル

■Must have:
Medical degree (M.D)
Licensed by a health authority to prescribe medicines (independent of supervision) for at least one year (post "intern/house officer" year) and has utilized the license to prescribe medicines in a patient care setting for an aggregate duration of at least one year.
Possesses the ability to critically evaluate medical/scientific information.
Excellent written and oral communication in English and Japanese.
Understands the design, development, and execution of clinical programs and studies.
Capacity to adapt to a fast paced and changing environment

■Preferred/Nice to have:
Documented work experience/knowledge of statistics
Training and experience in infectious diseases and/or infection control in the hospital setting is preferred.
Experience with investigational clinical trials is preferred.
Flexibility to join frequent late night/early morning teleconferences with international study teams.
Ability to travel domestically or internationally occasionally as required.

従業員数

4,861名

勤務地

東京都

想定年収

1,200 万円 ~ 1,800 万円

従業員数

4,861名

compliance Manager

大手外資系製薬企業

課長以上
外資系企業

仕事内容

Job Description Summary

Under the direction and guidance of the Head of Assurance, this position is responsible for conducting risk assessments and sample testing within the Annual Compliance Risk Cycle (ACRC), performing local monitoring activities, managing NEM/BCM programs, supporting misconduct investigations, and providing operational support for the Internal Review Committee (IRC). Through these activities, the role is responsible for timely identifying and assessing compliance and integrity risks and issues, verifying that Novartis business activities are conducted in accordance with applicable laws, regulations, and internal policies, and driving necessary corrective actions and continuous improvement initiatives.
当該ポジションは、Assurance部門ヘッドの方針及び指示のもと、ACRCにおけるリスク評価及びサンプルテスト、ローカルモニタリング、NEM/BCMならびに不正調査、IRCの運営支援を実施する。これらの活動を通じて、コンプライアンスおよびインテグリティに関するリスクや課題を適時に特定・評価し、ノバルティスの事業活動が法令、規制および社内ポリシー等に基づき適切に実施されていることを確認・検証するとともに、必要な是正および継続的改善を推進する。

Job Description
Major Accountabilities:

1. ACRC & Local Monitoring
• Conduct risk assessments, self-assessments, and sample testing under the ACRC and Local Monitoring programs.
・Verify and assess whether business activities are conducted in accordance with applicable laws, regulations, and internal policies, and drive improvement initiatives and corrective actions as necessary.

2. SpeakUp Case Management & IRC Coordination
• Support the intake, assessment, and escalation of compliance and integrity concerns as the Local SpeakUp Office Contact.
・Manage misconduct investigations and compliance-related cases, supporting fact-finding, root cause analysis, and the implementation of corrective actions.
・Support the operation of the Internal Review Committee (IRC) and facilitate appropriate responses to significant compliance and integrity matters.

3. BCM & NEM Support
• Support the maintenance and enhancement of disaster response and business continuity capabilities through the administration of BCM and NEM programs.
・Collaborate with relevant functions and support timely and appropriate responses during emergency situations.

4. Internal Audit & Business Governance Support
• Promote the effectiveness of the compliance management framework by supporting Internal Audit activities and the completion of corrective actions. ・Leverage insights gained from Assurance activities to support the strengthening of Business Governance and drive continuous improvement initiatives.

1. ACRC & Local Monitoring
• 事業活動が法令、規制および社内ポリシー等に基づき適切に実施されていることを確認•検証すると共に、改善活動および是正措置を推進ACRC及びLocal Monitoringにおけるリスク評価、セルフアセスメント並びにサンプルテストを実施

2. SpeakUp Case Management & IRC Coordination
• Local Speak Up Office Contactとして、コンプライアンス及びインテグリティに関する懸念事項の受付、評価及びエスカレーションを支援不正調査及びコンプライアンス事案への対応を実施し、事実確認、原因分析および是正措置の推進を支援IRCの運営を支援し、重要なコンプライアンス及びインテグリティの課題に対する適切な対応を推進

3. BCM & NEM support
• BCM及びNEMプログラムの運営を通じて、災害対応体制及び事業継続体制の維持強化を推進を支援

4. IA & Business Governance Support
・緊急事態発生時には関連部門と連携し、迅速かつ適切な対応を支援
• Internal Audit対応および是正措置の完了支援を通じて、コンプライアンス管理体制の有効性向上を推進
・各種Assurance活動から得られた知見を活用し、Business Governanceの強化及び継続的改善を支援する。

求める経験 / スキル

Additional Requirements / Expected Behaviors
•Businessの課題を深く理解し、専門性を活かした実践的かつ建設的なアドバイスを提供することで、組織全体の価値創出と成長に貢献すること
・変化を前向きに受け入れ、新たな役割や責任にも柔軟に対応し、自ら機会を見出して主体的に挑戦すること
・職責に関係なく他者を尊重し自らの担当領域にとらわれず役割や立場を超えて協働すること
・多様な意見や考え方を歓迎し、相互尊重に基づくオープンで建設的な組織文化の醸成に貢献すること
・専門性や実績だけでなく、周囲への敬意と信頼を通じて、共に成果を創出できる人材であること
・常に自己研鑽に励み、専門性だけでなく、論理的思考力、課題解決力、コミュニケーション力などの幅広い能力を高めるとともに、他者の成長を支援し、学び合う文化の醸成に貢献すること
・ERCを会社の成長を支える戦略的パートナーと認識し、「ERCで活躍した人材は会社のどこでも活躍できる」と評価される組織を共につくることその為に、ハードスキル・ソフトスキルの双方を高め続けるとともに、高い成果と周囲へのポジティブな影響力の両方を発揮できる人材を目指すこと
・ERCは専門性だけでなく、ビジネス視点、多様なステークホルダーとの協働、複雑な課題への対応力が求められる組織であり、この環境を自己成長の機会と捉え、高い志を持って挑戦し続けること
・Novartis Values & Behaviorsを体現し、部内外を問わず信頼されるメンバーとなれるよう意識して行動すること

勤務地

東京都

想定年収

1,300 万円 ~ 1,500 万円

滋賀工場　GMP製造管理責任者

参天製薬株式会社

課長以上
上場企業

仕事内容

工場長の指揮下にあって、「薬事法」「医薬品、医療機器等の品質、有効性及び安全性の確保等に関する法律施行令」及び「滋賀工場GMP管理基準書類」に従い、製品標準書、製造管理基準書又は製造衛生管理基準書に基づき以下5項目を基本使命とし医薬品の製造管理にかかる業務を管理いただきます。

（１）医薬品品質システム(PQS)の管理
　医薬品品質システムが適切に運用されるように管理する。

（２）製造プロセスの管理・監督
　原料・材料・製品の規格や製造手順が承認事項と一致するように管理する。

（３）改善活動の推進
　GMPシステムの運用状況を確認し必要に応じて改善提案する。

（４）逸脱対応
　逸脱発生時には、迅速に対応し必要な処置を指示する。

（５）メンバー育成
　製造部門のメンバーに対して適切な教育・指導を行いGMP遵守を徹底する。

また、滋賀・能登工場を横断した品質保証力の向上、人材育成、業務プロセス・システムの改革などベストプラクティスの構築により組織力強化に努め、グローバル市場での競争優位を推進いただきます。
特に品質保証力の向上に注力し、世界的に適合するGMP品質システムの構築と継続的な維持を通じて、顧客から信頼される適正な品質保証を達成することを目指します。

求める経験 / スキル

必須要件
- 製薬業界での5〜10年以上の経験。
- 製造管理上必要な法規制（薬事法、国内外GMP）に熟知すること、内部および外部監査への対応経験。
- 製造プロセスや構造設備を熟知しており、製造管理システムの構築、最適化と製造管理基準の立案・見直しができる。
- 医薬品製造の本質（安全性、有効性、均一性）を理解し、製造管理への落し込みができる。
- プロジェクトやタスクフォースのリーダー的経験があり、部門間との連携能力があり、実行管理を確実に担える。
-
希望条件
- 学歴: 工学、薬学、化学、または関連分野の学士号以上。修士号が望ましい。
- LEAN、生産性向上活動（例：Six Sigma）の経験
- 英語スキル（読み書きおよび会話レベル）

従業員数

3,968名（(2026年3月31日現在)）

勤務地

滋賀県

想定年収

1,000 万円 ~ 1,400 万円

従業員数

3,968名（(2026年3月31日現在)）

Regulatory Affairs Assoc. Dir

外資系動物薬メーカー

課長以上
外資系企業

仕事内容

【POSITION OVERVIEW】
The Associate Director of the Regulatory Affairs (RA) is responsible for the overall management of regulatory affairs activities including pharmacovigilance work at RA department at PDRA division Animal Health in Japan. The position requires a combination of scientific knowledge, understanding of regulatory requirements, strategic thinking, and team leadership to ensure timely development of new products and regulatory affairs activities.
The individual will ensure that the RA team develops and successfully executes project plans for timely product registrations.
The individual will motivate and encourage the RA Team to perform successfully and will mentor and coach team members to oversee their personal development in the organization.
The individual will closely communicate with members at the Product Development department to optimize the regulatory submission and get products approved.

【Reporting lines】
The RA Associate Director reports directly to the PDRA director
The RA Associate Director manages a team of 5-7 colleagues of RA department.

【PRIMARY ACTIVITIES】
Support PDRA director to optimize/maximize PDRA’s activities by following ways:
Build PDRA as one team to have a seamless communication/collaboration
Review/advice Gap analysis done at PD department and create PDRA’s one
Set up agreed product profiles among PD and RA.
Harmonize local requirements into the global development plan based on the well-prepared development plan.
Liaise with Sales BU in the identification of market potential/requirements for new vaccines, vaccine improvements and pharmaceutical products
Oversee the scientific quality of work within the unit to maintain and enhance reputation for excellence
Lead the RA team to ensure timely development of biological and pharmaceutical veterinary products in Japan in compliance with the general pharmaceutical guidelines and with local laws.
Ensure that the RA team develops optimized development plan by leveraging global data.
Oversee the collaborations with Contract Research Organizations (CROs). Ensure contract management and quality oversight of CROs.
Ensure compliance of organizational structures, internal processes, operational activities & reporting including national and overseas pharmacovigilance requirements in line with the respective pharmaceutical law guidelines
Provide advice on research issues, problems and trends having significant impact on RA activities of short and long-term goals
Optimize the performance of RA colleagues by coaching, motivating, training and evaluating them properly in line with global and local development program, including setting and reviewing individual yearly objectives and development plans

求める経験 / スキル

【BACKGROUND REQUIREMENTS】
Following leadership behaviors are expected

・Be Purposeful – Capturing the meaning of our work, following our mission to improve people’s lives and adhere to ethical behaviors.
・Be empowering – Unfolding potential in self and others by providing guidance, driving personal development, and sharing enthusiasm.
・Be collaborative – Working together across departments, encouraging teamwork that respects diverse backgrounds and culture differences.
・Be Results-driven – Setting ourselves stretch performance target as well as establishing as establishing a feedback culture and taking responsibility.
・Be innovative – Constantly experimenting and driving change initiatives. This includes being open to new ideas. Making quick decisions and taking risks.
・Be future-oriented – Continuously seeking best practice solutions and embracing opportunities of new technologies to shape the future of our business.

〇Education
Veterinarian or PhD in Biological or Animal Sciences preferable.

〇Experience
・Minimum 7 years of relevant experience in a regulated industry, preferably healthcare, most preferably in the field of veterinary vaccines or pharmaceuticals.
・Knowledge of Japanese Regulatory System preferable
・Experience leading teams and developing/coaching people to maximize people/team capability.
・Working in a matrix environment with multiple stakeholders at local and global levels.
・Experience in planning and drafting budgets.

〇Skills, Knowledge and Competencies
・Language – Japanese (fluent), English (professional level – verbal and writing)
・Highly developed skills in negotiating, influencing, leadership and staff motivation.
・Excellent communication and organizational skills.
・Ability to work well with other departments in a multicultural team setting and matrix organization
・Familiarity with animal diseases and animal husbandry techniques and ability to understand our product users including farmers and veterinarians.
・Knowledge of Microsoft Office

勤務地

東京都

想定年収

750 万円 ~ 1,600 万円

ブランドマネージャー

大手外資製薬会社（希少疾病領域）

課長以上
外資系企業

仕事内容

・製品戦略および中長期的なマーケティングプランの策定
・製品戦略に基づき、資材・イベント・デジタル施策の計画・実行
・KOLマネジメントの遂行
・領域の疾患啓発活動の統括
・関連する社内及び社外ステークホルダーと連携し、製品価値の最大化

求める経験 / スキル

・製薬業界での経験（5年以上）
・製薬業界でのマーケティング経験（3年以上）
・英語：中級ビジネスレベル

勤務地

東京都

想定年収

800 万円 ~ 1,450 万円

Quality Assurance

大手外資製薬メーカー

外資系企業
上場企業

仕事内容

主な業務:
APAC地域（日本を含む）のGCP監査、主に医療機関監査を担当する。供給業者、Third party collaborationsとの協力、およびデューデリジェンス活動が含まれる場合があります。
APAC地域（日本を含む）でのQA監査を準備、実施し、監査報告書を作成し、関連するQA管理および外部の関連する利害関係者（例: 臨床運営）に結果を伝え、是正および予防措置が適用されるようにさまざまなチームと連携してQA observationを解決する。
チーム内での特定のタスクと業務を主導し、重要な成果物に向けて時間と努力を優先し、高品質な作業を生み出す
個々の役割で卓越し、自身のスキルを向上させるために積極的に取り組むことで、チーム全体の目標に貢献する
他の同僚と影響を与え、協力し、連携する
品質に重要な要因を分析し活用して潜在的なリスクを特定し、リスクベースの監査を準備および実施する能力を持つ
リスク評価に基づき、適切に監査対象を特定し、スケジュールに組み込むためにQALをサポートする。
プロジェクト/製品における潜在的な不正行為や重大な逸脱の問題を含む品質問題を適切かつ迅速にエスカレーションする。
適用されるQA functional line に日常的なサポートを提供し、割り当てられた試験の適切な品質監視を確保する。
品質管理ユニットのメンバーとして、日本国内の利害関係者に日常的なサポートを提供する。
臨床試験実施施設、供給業者、研究活動、臨床試験報告書および提出文書、ならびにICH（国際調和会議）、適用される政府機関の規制/ガイドライン、会社の方針、手順および業界標準に対するCountry Office（CO）のプロセスの遵守を評価する。限定的な監督の下で、内部および外部でさまざまなGCPおよびPVトピックに関する意識向上のためのセッションを開発および提供する。
QA内での監査アプローチの標準化を促進する。
技術的専門知識のある分野で新しい監査技術/支援を提案することが日常的に行われる。
QA内の職場環境/文化が会社のリーダーシップ行動を体現していることを確保する。
特に監査関連プロセスにおいて、PMDAの適合性調査でPMDA調査官に対応する。

求める経験 / スキル

学歴
BS/BA学位または同等の資格、または関連分野での経験を有し、この役割に必要な主要な活動および基本的なスキルに精通していること。

経験
製薬会社またはCROでの実務的なGCP（臨床試験）監査経験が5年程度以上あり、On-siteおよび Remote監査の両方を含む。
ICH-GCP、日本の医薬品医療機器法（PMD法）、および主要な管轄区域（例：FDA、EMA）の臨床試験規制に関する実務知識。
臨床開発の知識。プロトコル開発、倫理審査、インフォームドコンセント、被験者の選定と登録、データ収集と管理、モニタリング、治験薬管理、重篤な有害事象の処理、データクリーンアップ、研究報告書の作成を含む、臨床試験プロセス全体。
臨床監査経験。監査計画、監査実施、監査報告書作成、是正および予防措置（CAPA）の提案のフォローアップにおける実務経験。
グローバルチームまたは多国籍プロジェクトでの経験、またはグローバル環境で働くための強い意欲と適応力。

勤務地

東京都

想定年収

900 万円 ~ 1,500 万円

MSL（Neurology）

外資製薬企業

課長以上
外資系企業

仕事内容

【ポジション概要】
メディカル・サイエンス・リエゾン（MSL）は、フィールドを基盤とする科学・医学の専門家として、医療従事者および主要な社外専門家との質の高い非プロモーションの科学的情報交換を通じて、ローカルのメディカル戦略を実行します。双方向の科学的対話を促進し、実行につながるフィールドインサイトを創出するとともに、ローカルのメディカル戦略に沿ったエビデンス創出および情報発信を支援することで、社外のメディカルコミュニティと社内ステークホルダーをつなぐ重要な役割を担います。本ポジションはCommercial部門から独立して活動し、適用される法規制および社内ポリシーを完全に遵守します。

【主な職務】
■科学的・社外エンゲージメント
主要な社外専門家、学術機関、および関連する医療従事者との専門的な関係を構築・維持します。疾患、臨床データ、治療環境、進行中の研究について、専門家同士の科学的情報交換を行います。
Centers of Excellence、紹介・連携ネットワーク、新たな専門家の特定を含むステークホルダーマッピングに貢献します。
自発的に寄せられた医学的問い合わせに対し、コンプライアンスを遵守し、科学的にバランスの取れた形で対応します。
必要に応じて、学会、アドバイザリーボード、教育フォーラム等において社を代表します。Medical Leadおよび社内ポリシーに沿って、患者支援団体と科学的テーマについてエンゲージメントを行います。
社内手順に従い、フィールドメディカル活動を正確に記録します。

■フィールドインサイトの創出
臨床実践、アンメットメディカルニーズ、診断上の課題、および変化する治療パラダイムに関するインサイトを収集し、整理・統合します。エビデンスギャップおよび新たな科学的トレンドを特定します。 Medical Leadおよびクロスファンクショナルのステークホルダーに対し、タイムリーかつ質の高いフィードバックを提供します。
体系的なインサイトレポーティングを通じて、メディカル戦略の改善・精緻化に貢献します。

■エビデンス創出支援
医師主導研究（IIT）および会社主導研究の実施可能性評価を支援します。社内ポリシーに沿って、研究者との科学的ディスカッションを促進します。ローカル戦略に沿った研究協働の機会の特定を支援します。
パブリケーション戦略に沿ったデータ発信活動を支援します。

■コンプライアンス＆ガバナンス
すべての活動を、国内の法規制、業界コード、および社内SOPを厳格に遵守して実施します。プロモーション活動との明確な分離を維持します。高い倫理的判断力を発揮し、科学的インテグリティを重視して行動します。

求める経験 / スキル

応募資格：
生命科学分野の高度な学位（PharmD、PhD、MD、または同等の学位が望ましい）

経験・スキル：
Medical Affairs、MSL、または関連する科学・医学領域の職務経験3～6年
神経領域の経験必須。希少疾患領域の経験が望ましい
高い科学的専門性を有し、臨床データを解釈し、分かりやすく伝える能力
信頼に基づく科学的な関係を構築した実績
変化の大きい環境、または上市前環境での業務経験が望ましい
複雑なフィールド情報を統合し、実行可能なインサイトへと落とし込む能力
フィールドベースの環境で自律的に業務を遂行する能力
ビジネスレベルの英語力が望ましい

勤務地

東京都

想定年収

1,000 万円 ~ 1,400 万円

ペーシェントアドボカシー

外資スペシャリティーファーマ

課長以上
外資系企業

仕事内容

複数事業領域にまたがるペイシェント・アドボカシー戦略の策定・実行
各事業領域における患者ジャーニー、アンメットニーズ、ステークホルダー環境の違いを踏まえ、事業領域ごとの優先事項を設定する。

事業および患者のニーズを、優先事項、マイルストーン、KPI、必要なリソース、予算を含む年間アドボカシー計画に落とし込み、翌年度の活動アジェンダを明確に管理する。

3つの事業領域における活動の優先順位を適切に設定しつつ、一貫性のある患者政策上のメッセージと、統一されたエンゲージメント基準を維持する。
Global Government & Public AffairsおよびGlobal Patient Advocacyの担当者と連携し、日本とグローバルの優先事項の戦略的な整合を図る。

求める経験 / スキル

大学卒業以上。生命科学、公衆衛生、薬学、公共政策、経営学またはマネジメント分野の修士号があれば尚可。これらに相当する実務経験も可。
日本語および英語の読み書き・会話における高い運用能力が必須。
日本の製薬・ヘルスケア業界において、ペイシェント・アドボカシー、パブリック・アフェアーズ、マーケットアクセス、ガバメント・アフェアーズ、政策、対外活動、または関連分野で7～10年以上の実務経験。
患者団体とのパートナーシップを構築・管理し、患者インサイトを戦略、政策、患者アクセス、または事業上の意思決定に反映した実績。

勤務地

東京都

想定年収

1,000 万円 ~ 1,400 万円

原薬及び製剤に関する製造技術移転プロジェクトや、変更管理に伴う技術検討プロジェクトのプロジェクトマネジメント業務

第一三共株式会社

上場企業

仕事内容

【職務内容】
研究所等から社内外の製造サイトへの製造技術移転プロジェクトを推進し、計画通り技術移転を完了する。
サプライチェーン、品質保証およびCMC薬事関係者との協業によって商用製造体制を確立する。
委託先（CMO/CDMO）選定にあたって、研究所と協力して技術面から評価を行い、同時にビジネス・品質面からその他関係者と調整して最適な委託先を選定する。

【入社後のキャリアパス】
適性により、グローバル低分子品目やNewModality品目の海外製造サイトへの技術移転プロジェクトを担当することが考えられる。
また国内医薬品（長期収載品含む）の国内需給を管理するサプライチェーン部門での活躍が期待できる。

求める経験 / スキル

【求める経験】
《必須》
低分子医薬品原薬・製剤の製造プロセス開発に従事した経験。
製造サイトへの製造プロセス技術移転の経験。
プロジェクトマネジメント経験。
協調性があり多くのステークホルダー、専門家とのコミュニケーションを苦とせずに良好な関係が築けること

《尚可》
海外製造サイトへの技術移転の経験。
バイオロジクスの製造プロセス開発に従事した経験。
英語力（TOEIC 730点）

従業員数

20,171名（連結）

勤務地

神奈川県

想定年収

800 万円 ~ 1,400 万円

従業員数

20,171名（連結）

年収1,400万円以上／医薬品の求人・転職情報

Commercial FP&A Manager~Senior Manager

QA Senior Manager_ Biopharma

Corporate FP&A Manager - Senior Manager

Ethics & Compliance

Marketing of Rare Tumors /Biopharma

National Account Manager

テクニカルサービス

Senior Manager, Learning Business Partner - Drug Development

Medical Advisor（感染症ワクチン領域）

品質管理部長 ＜秋田常駐／バイオ医薬品製造施設立上げ・品質管理統括＞

製造部長 ＜秋田常駐／バイオ医薬品製造施設立上げ・製造統括＞

エンジニアリング責任者 ＜新規合弁会社 / バイオ医薬品製造施設建設・立ち上げ・運営＞

Marketing & Communications Manager（希少疾患）

DX業務リーダー

海外臨床開発責任者

メディシナルケミスト ～計算科学チームとの連携～

人事総務部長

Compliance Director – Business Partnering & Advisory, Japan

シニアブランドマネージャー

Vaccine Medical Manager

パブリック・アフェアーズ（広報）アソシエイト・ディレクター

Medical Affairs TA Head

[Pfizer] Senior Manager for Policy:4963413

グローバルQA企画リード

＜倫理・コンプライアンス本部＞Ethics & Compliance/Senior Director/神戸本社

[Pfizer] Senior Manager, Business Development

APAC Compliance Manager

ADME研究チームリーダー／プリンシパルADMEサイエンティスト

非臨床Modeling and Simulation担当者

[Innovative Medicine] R＆D, Principal Scientist, CMC Group, CMC Sciences, Regulatory Affairs R-099692

Manager, Japan Country Quality

Senior MSL

Engagement and Innovation Lead/Manager/Global ExpMED Inflammation

Clinical Development Senior Manager

Sr. Manager, Patient Safety

製造リーダー（注射剤・固形剤）

Clinical Site Partner, Clinical Operations

[Innovative Medicine] R&D, Sr. Scientist Biostatistics, Statistics & Decision Sciences Japan, Global Development (R-079886)

Clinical Trial Physician

Senior Manager, Portfolio and Program Manager

Senior Manager, Senior Japan Clinical Lead

Clinical Development Medical, Associate Director, Research and Development - Vaccines

compliance Manager

滋賀工場 GMP製造管理責任者

Regulatory Affairs Assoc. Dir

ブランドマネージャー

Quality Assurance

MSL（Neurology）

ペーシェントアドボカシー

原薬及び製剤に関する製造技術移転プロジェクトや、変更管理に伴う技術検討プロジェクトのプロジェクトマネジメント業務

職種から求人を探す

業種から求人を探す

勤務地から求人を探す

年収から求人を探す

エントリー確認

品質管理部長　＜秋田常駐／バイオ医薬品製造施設立上げ・品質管理統括＞

製造部長　＜秋田常駐／バイオ医薬品製造施設立上げ・製造統括＞

エンジニアリング責任者　＜新規合弁会社 / バイオ医薬品製造施設建設・立ち上げ・運営＞

メディシナルケミスト　～計算科学チームとの連携～

滋賀工場　GMP製造管理責任者